This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.
Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.

Start Date01 Jan 2025

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

[+2]

NCT06185972 / RecruitingPhase 2IIT

Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II

The objective of this study is to demonstrate the efficacy and response of novel Magnetic Resonance Imaging (MRI)-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

Start Date25 Jul 2024

Sponsor / Collaborator

Sunnybrook Health Sciences Centre

[+1]

NCT06654804 / RecruitingPhase 4IIT

Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury

Patients with traumatic spinal cord injury (tSCI) often suffer from spinal cord swelling inside the thecal sac, which contains the spinal cord and surrounding fluid, leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury. The combination of increased pressure and decreased blood flow causes vascular hypoperfusion of the spinal cord and exacerbates the severity of injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypoperfusion would allow the treating physician to optimize the hemodynamic condition of the patient with acute spinal cord injury and potentially improve functional outcomes.

Start Date28 Sep 2023

Sponsor / Collaborator

University of Washington

[+1]

100 Clinical Results associated with Perflutren lipid microsphere

100 Translational Medicine associated with Perflutren lipid microsphere

100 Patents (Medical) associated with Perflutren lipid microsphere

341

Literatures (Medical) associated with Perflutren lipid microsphere

01 Feb 2025·AMERICAN JOURNAL OF CARDIOLOGY

Comparative Safety of Ultrasound Enhancing Agents: A Systematic Review and Bayesian Network Meta-Analysis

Article

Author: Cabra, Arturo ; Gueco, Myra ; Gonzalez, Ricardo De La Fuente ; Naslazi, Emi ; Liu, Daphne ; Fu, Shuai ; Dunham, Dustin M ; Maliszewska, Zuzanna ; Hummel, Noemi

Ultrasound enhancing agents (UEAs), including Optison, DEFINITY, and LUMASON, enhance the diagnostic performance of echocardiography, particularly, in patients with suboptimal acoustic windows. However, there remains a paucity of comparative safety assessments among the Food and Drug Administration-approved UEAs. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic literature review performed in August 2023 searched Medline, Embase, Cochrane Library, and gray literature. Randomized and nonrandomized comparative evidence on safety of contrast-enhanced procedures were included. A feasibility assessment ensured homogeneity across studies by comparing patient characteristics and outcomes. Bayesian hierarchical network meta-regression was used to indirectly compare published safety outcomes across different UEAs. In addition, adverse events (AEs) between 2019 and 2023 for each UEA were retrieved from the Food and Drug Administration Adverse Events Reporting System (FAERS), and comparative safety outcomes were derived using annual UEA administration in the United States. The screening of 4,146 records rendered 19 studies for inclusion in the indirect comparison analysis after feasibility assessment. Optison demonstrated favorable safety in direct comparisons with DEFINITY and LUMASON across the majority of investigated AEs. Network meta-regression results on serious AEs within 30 minutes revealed odds ratios (ORs) of 0.59 (95% confidence interval 0.27 to 1.23) and 0.63 (0.29 to 1.33) for Optison versus LUMASON and DEFINITY, respectively, indicating a decreased risk of serious AEs for Optison versus LUMASON and DEFINITY, further supported by statistically significant ORs within FAERS: 0.01 (0 to 0.02), p <0.001 and 0.15 (0.05 to 0.48), p = 0.001 for Optison versus LUMASON and DEFINITY, respectively. In conclusion, our results restate the favorable comparative safety profile of Optison, providing new evidence to inform clinical decision-making.

01 Dec 2024·CURRENT EYE RESEARCH

Autologous-Fibrin Induction: A Novel Approach for Sutureless Sclerotomy Closure in Pars Plana Vitrectomy

Article

Author: Aykut, Veysel ; Kunbaz, Ahmad ; Oguz, Halit ; Durmus, Ebubekir ; Kaya, Sabire Pelin ; Esen, Fehim

PURPOSE:

This study presents a novel sutureless closure approach for sclerotomies following pars plana vitrectomy (PPV) and assesses its efficacy and safety.

METHODS:

A total of 142 eyes were included in the study. PPV procedures were performed using 23-gauge (23 G) or 25-gauge (25 G) systems. Preoperative characteristics, intraoperative findings, and postoperative outcomes were documented.

RESULTS:

The cohort included 80 males and 62 females (mean age: 60.4 ± 12 years), primarily undergoing surgery for retinal detachment (59%). Among the patients, 87% underwent 25 G PPV (35% three-port, 52% four-port), while 13% underwent 23 G PPV (12% three-port, 1% four-port). Gas tamponade was administered in all cases, with perfluoropropane used in 45.7% of instances, sulfur hexafluoride in 29.5%, and air in 24.6%. Spontaneous closure was observed in 9.4% (47 of 501) of sclerotomies, autologous-fibrin induction approach successfully closed 75.8% (380 of 501) of the sclerotomies (83.7% of leaking sclerotomies) and 14.7% (74 of 501) of sclerotomies needed sutures. Visual acuity improved postoperatively, and first-day hypotony rate was 6.3%. Importantly, no serious complications such as choroidal detachment or endophthalmitis were observed during the postoperative period.

CONCLUSION:

The autologous-fibrin induction offers a simple, cost-efficient, and reliable approach for sutureless sclerotomy closure in PPV, with promising outcomes.

01 Dec 2024·JAMA Ophthalmology

Tissue Plasminogen Activator or Perfluoropropane for Submacular Hemorrhage in Age-Related Macular Degeneration

Article

Author: Saleh, Azahir ; Ayis, Salma ; Steel, David H. ; Mehta, Alex ; Jackson, Timothy L. ; Membrey, Luke ; Murphy, George S. P. ; Costen, Mark ; Cheema, Muhammad Raza

Importance:

Evidence is limited to support therapies to treat submacular hemorrhage (SMH) secondary to neovascular age-related macular degeneration (AMD) as an adjunct to anti–vascular endothelial growth factor therapy (anti-VEGF).

Objective:

To determine if intravitreal tissue plasminogen activator (TPA) or gas improves visual acuity or promotes resolution of SMH secondary to neovascular AMD in eyes treated with ranibizumab.

Design, Setting, and Participants:

This was a double-masked, sham-controlled, factorial randomized clinical trial and feasibility study that recruited participants from June 2014 to March 2019, with 12 months’ follow-up. Included in the trial were patients from 4 UK vitreoretinal units who had fovea-involving SMH of at least 1 disc area secondary to neovascular AMD and were evaluated within 14 days of onset.

Interventions:

Study eyes received baseline ranibizumab and were then randomized 2:1:1:1 to 1 of 4 intravitreal treatments: sham injection, perfluoropropane (C3F8), TPA, or combined C3F8 and TPA (C3F8 + TPA). All eyes received monthly pro re nata ranibizumab therapy over 12 months. Outcome assessors were masked to intervention assignment.

Main Outcome and Measure:

Best-corrected visual acuity (BCVA) at month 3.

Results:

Fifty-three of 56 participants (95%; mean [SD] age, 81.5 [8.1] years; 33 female [59%]) reached the primary end point. Study eyes were randomized to the following intravitreal treatments: sham injection (n = 23), C3F8 (n = 11), TPA (n = 11), or C3F8 + TPA (n = 11). On factorial analysis, the combined TPA groups had significantly better month 3 mean logMAR BCVA than those not receiving TPA: 0.66 vs 0.98 (μd = −0.32; 95% CI, −0.58 to −0.07; P = .02). There was no statistically significant difference comparing groups that did vs did not receive C3F8: 0.80 vs 0.90 (μd = −0.11; 95% CI, −0.37 to 0.16; P = .43). The combined TPA groups were less likely to have SMH present at month 1 (10 of 18 [55.6%] vs 21 of 24 [87.5%]; P = .03), a benefit not evident in the combined gas groups. The mean logMAR BCVA at 3 months was not significantly different between the groups: monotherapy control, 0.99; C3F8, 0.97 (vs control μd = −0.02; 95% CI, −0.48 to 0.44); TPA, 0.70 (vs control μd = −0.29; 95% CI, −0.79 to 0.21); combined C3F8 and TPA, 0.71 (vs control μd = −0.36; 95% CI, −0.82 to 0.11); P = .11. No safety differences were identified across the treatment groups.

Conclusions and Relevance:

Results of this randomized clinical trial suggest that TPA may increase the chance of visual acuity gain when added to ranibizumab therapy for neovascular AMD in eyes with SMH, warranting consideration of additional clinical trials.

Trial Registration:

ClinicalTrials.gov Identifier: NCT01835067

News (Medical) associated with Perflutren lipid microsphere

22 Jul 2022

·www.sciencedaily.com

Porous crystals bind fluorine-containing greenhouse gases

Fluorine-containing gases -- including so-called per- or polyfluorinated hydrocarbons, or PFCs -- have a significant share in global warming. Researchers recently developed new crystalline materials that can selectively adsorb the molecules of such carbon-fluorine bonds. They hope that these porous crystals may be useful for targeted binding and recovery of PFCs. Emissions of greenhouse gases contribute significantly to global warming. Not only carbon dioxide (CO2) but also fluorine-containing gases -- including so-called per- or polyfluorinated hydrocarbons, or PFCs -- have a significant share in this development. Researchers at the Institute of Organic Chemistry of Heidelberg University led by Prof. Dr Michael Mastalerz recently developed new crystalline materials that can selectively adsorb the molecules of such carbon-fluorine bonds. The Heidelberg researchers hope that these porous crystals may be useful for targeted binding and recovery of PFCs. Polyfluorinated carbons are organic compounds of various lengths in which the hydrogen atoms of alkanes are partly or fully replaced by fluorine atoms. These atoms are chemically highly stable. They are not ubiquitous in nature and are used mainly for etching processes in the semiconductor industry, in eye surgery, and in medical diagnostics as contrast enhancers for certain ultrasound examinations. "Unlike CO2, which is integrated in natural material cycles, PFCs accumulate in the atmosphere and stay there for several thousands of years before breaking down," stresses Prof. Mastalerz. Compared to carbon dioxide, PFCs thus have a much greater global warming potential -- the impact of one PFC molecule is virtually equal to 5,000 to 10,000 CO2 molecules. According to the researcher, that makes polyfluorinated hydrocarbons a permanent problem that is not only contributing to global warming now but accelerating it as well. With his research group at the Institute of Organic Chemistry of Heidelberg University, Prof. Mastalerz has developed a new type of crystalline material that can adsorb polyfluorinated hydrocarbons highly selectively, i.e., binding them to its interior surface. The porous crystals are based on shape-persistent organic cage compounds that carry fluorine-containing side chains on the interconnected struts. These side chains react according to the "like attracts like" principle via fluorine-fluorine interactions with the PFC molecules, ensuring they are deposited on the inner surface of the material. In their experiments, the Heidelberg researchers proved that the crystals they developed bind certain fluorine-containing gases such as octafluoropropane or octafluorocyclobutane approximately 1,500 to 4,000 times more strongly than dinitrogen, the main component of air. According to Prof. Mastalerz, these numbers represent extraordinarily high selectivities to bind such PFCs. Currently Prof. Mastalerz and his team are working on further increasing the selectivity of the crystals and transferring the process to other fluorinated gases, such as those used in medical anaesthesia. "I see enormous potential for development in this area," emphasises the researcher. He hopes that the adsorbent can be used for recovery of polyfluorinated hydrocarbons at their point of use. The German Research Foundation funded the research.

27 May 2021

·www.biospace.com

Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer

PYLARIFY will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the U.S. by year end NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved PYLARIFY, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent to identify suspected metastasis or recurrence of prostate cancer. PYLARIFY is the first and only commercially available approved PSMA PET imaging agent for prostate cancer. The product will be immediately available in parts of the mid-Atlantic and southern regions and availability is expected to rapidly expand over the next six months with broad availability across the U.S. anticipated by year end. “The FDA approval of PYLARIFY is a significant milestone for Lantheus and the prostate cancer community in the United States. We believe PYLARIFY represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors, along with patients and their families, can make more informed treatment decisions,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “I would like to thank the patients who participated in our clinical trials, the study investigators and our employees, whose efforts made this achievement possible.” Identification of suspected metastatic disease in men considering initial definitive therapy is important to optimize treatment planning and to avoid futile interventions. Of men with localized prostate cancer who undergo initial curative intent/management, up to 50% may experience recurrence of their disease within ten years of treatment.1 Recurrent disease is often detected by a rise in serum prostate-specific antigen (PSA) levels; however, conventional imaging, especially at low PSA levels, is not able to identify the location and extent of the disease in the majority of cases.2,3 PYLARIFY was developed to target PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.4 PYLARIFY binds to the target, enabling the reader of the PET scan to detect and locate the disease. Cyclotron production of F 18 offers high batch capacity and high image resolution, and F 18’s 110-minute half-life allows for wide geographic distribution.5,6 “Conventional imaging has significant limitations in detecting prostate cancer, both in initial staging and when the cancer has recurred or spread after initial primary treatment. Specifically, standard imaging poorly detects the early spread to distant organs, such as the lymph nodes, bones, and other organs,” said Michael J. Morris, M.D., Prostate Cancer Section Head, Genitourinary Medical Oncology, Memorial Sloan Kettering Cancer Center and the Lead Study Investigator in the CONDOR trial and Study Investigator in the OSPREY trial. “PYLARIFY can detect the spread of disease well before standard imaging and can be a transformative diagnostic tool that helps clinicians develop treatment plans based on a much more accurate understanding of a patient’s distribution of disease.” “We believe today’s approval is a game-changer for men facing prostate cancer," said Jamie Bearse, Chief Executive Officer of ZERO - The End of Prostate Cancer, a Patient Advocacy Group. "Having a diagnostic tool that allows doctors to see suspected metastatic or recurrent prostate cancer earlier, anywhere in the body, is a significant step forward and will have a tremendous impact on patients' lives.” The approval of PYLARIFY is based on data from two Company-sponsored pivotal studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance of PYLARIFY across the prostate cancer disease continuum. Results from OSPREY (Cohort A) demonstrated improvement in specificity and positive predictive value (PPV) of PYLARIFY PET imaging over conventional imaging in men at risk for metastatic prostate cancer prior to initial therapy. CONDOR studied men with biochemical recurrent prostate cancer. In patients with biochemical recurrent prostate cancer and non-informative baseline imaging, PYLARIFY demonstrated high correct localization and detection rates, including in patients with low PSA values (median PSA 0.8 ng/mL). In the clinical trials, PYLARIFY was well tolerated. In OSPREY and CONDOR, 593 patients with various states of prostate cancer were exposed to a single dose of PYLARIFY. Adverse reactions (headache, dysgeusia and fatigue) were reported in ≤ 2% of patients within the studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction. About PYLARIFY® PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging2, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1,5,7,8,9 About Prostate Cancer Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.10 PYLARIFY® (piflufolastat F 18) Injection Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Important Safety Information Contraindications None. Warnings and Precautions Risk of Image Misinterpretation Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Hypersensitivity Reactions Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available. Radiation Risks Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. Adverse Reactions The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions. Drug interactions Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established. To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or . For important risk and use information about PYLARIFY Injection, please see Full Prescribing information. About Lantheus Holdings, Inc. Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit . Safe Harbor for Forward-Looking and Cautionary Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) a delay in obtaining, or failure to obtain, FDA approval for additional PET manufacturing facilities that will manufacture PYLARIFY; (ii) the Company’s ability to successfully launch PYLARIFY as a commercial product; (iii) the ability of the Company’s third party PET manufacturing facilities and radiopharmacies to supply PYLARIFY to the market; (iv) the market receptivity to PYLARIFY as a new diagnostic agent; (v) the safety and efficacy of PYLARIFY; (vi) the intellectual property protection of PYLARIFY; and (vii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q). 1Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1. 2Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828. 3Taneja Imaging in the Diagnosis and Management of Prostate Cancer Rev Urol. 2004 Summer; 6(3): 101–113. 4Ceci & Fanti. PSMA-PET/CT imaging in prostate cancer: why and when. Clinical and Translational Imaging volume 7, pages 377–379 (2019). 5Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894. 6Martiniova et al. Gallium-68 in Medical Imaging Curr Radiopharm 2016;9(3):187-207. doi: 10.2174/1874471009666161028150654. 7Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290- 8Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689 9PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company 10American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021. View source version on businesswire.com:

Diagnostic ReagentsSmall molecular drugCollaborate

01 Apr 2021

·www.biospace.com

Lantheus Announces Retirement of Michael P. Duffy, Senior Vice President and General Counsel

April 1, 2021 12:30 UTC Names Daniel Niedzwiecki as Senior Vice President and General Counsel NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced that Michael P. Duffy, Senior Vice President, Law and Public Policy and General Counsel will retire from Lantheus on June 4, 2021 after more than 13 years with Lantheus. Mr. Duffy will be retained in an advisory capacity. His responsibilities will be assumed by Daniel Niedzwiecki, who has been with the Company since 2013 and will report directly to Mary Anne Heino, President and CEO. “On behalf of the entire Lantheus team and Board of Directors, I thank Mike for his many years of dedicated service to Lantheus and the radiopharmaceutical industry,” said Mary Anne Heino, President and Chief Executive Officer. “Mike is the consummate professional, a trusted advisor, a good friend, and it has been my absolute privilege to have worked with him. We wish Mike all the very best as he embarks on new adventures in his retirement.” “I am honored and privileged to have been part of the team that, starting in 2008, transformed a private equity-backed carve-out from Bristol Myers Squibb into a free-standing public company with a growing product portfolio and pipeline, and a market cap that has expanded by more than seven times since the Company’s IPO in 2015,” said Mr. Duffy. “With the integration of last year’s acquisition of Progenics well advanced, now is an appropriate time for me to step back to pursue other interests. Dan has been an integral member of our strong legal team since 2013, and I believe he is the right leader to continue to help drive the business forward and create additional value for our stakeholders.” About Lantheus Holdings, Inc. Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit .

AcquisitionCollaborateIPO

100 Deals associated with Perflutren lipid microsphere

External Link

KEGG	Wiki	ATC	Drug Bank
D01738	Perflutren lipid microsphere	V08DA04	DB00556

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Heart Diseases	CN	China Resources Double-Crane Pharmaceutical Co., Ltd.	15 Nov 2022
Contrast agents	US	Lantheus Medical Imaging, Inc.	31 Jul 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kidney Diseases	Phase 3	CN	China Resources Double-Crane Pharmaceutical Co., Ltd.	10 Nov 2017
Kidney Diseases	Phase 3	CN	Lantheus Medical Imaging, Inc.	10 Nov 2017
Liver Diseases	Phase 3	CN	China Resources Double-Crane Pharmaceutical Co., Ltd.	21 Sep 2017
Liver Diseases	Phase 3	CN	Lantheus Medical Imaging, Inc.	21 Sep 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04185246 (CTgov)	Phase 1/2	Heart Diseases	36	NH002 (Cohort 1)	fnttcbnyht(rmdxzudemh) = oyrvhaqbgl yauvwrjlzt (hhbcvurmqq, dsuwykdrop - rivcxibeoi) View more	-	20 Dec 2024
				NH002 (Cohort 2)	fnttcbnyht(rmdxzudemh) = giannzrglm yauvwrjlzt (hhbcvurmqq, khrmjwdndn - ybhjwakglx) View more
NCT01835067 (Pubmed \| JAMA Ophthalmol)	Phase 2/3	Age Related Macular Degeneration	56	Intravitreal Tissue Plasminogen Activator (TPA)	abrxuualbk(ylyaiuvkxc) = lebulrmxaa yhjqfibbdb (qcmfpjeesy )	Positive	17 Oct 2024
				Perfluoropropane (C3F8)	abrxuualbk(ylyaiuvkxc) = yfsnrbbbkx yhjqfibbdb (qcmfpjeesy )
TAPAS (EURETINA2024)	Not Applicable	Age Related Macular Degeneration	56	C3F8	numguoflkw(netpioofkt) = hellkgmggl xywylsijrf (aesjqpjcgk )	Positive	19 Sep 2024
				TPA	numguoflkw(netpioofkt) = jqlzwlrhvr xywylsijrf (aesjqpjcgk )
NCT04118764 (CTgov)	Not Applicable	Alzheimer Disease	6	Neuronavigation-guided single-element focused ultrasound transducer+Definity	bmixxtnsee(uaehjkmugd) = hkemxgngys ohuewvkfrk (akiiscytib, ljwzvebygw - kvvokylwdg) View more	-	26 Aug 2024
CTR20171087 (Pubmed \| BMC Pharmacol Toxicol)	Phase 1	-	-	perflutren lipid microsphere injection (DEFINITY®) (Male subjects)	qryohswfcz(fwhgoemlhv) = rnuzrnkieq fwswonsqgf (swgbjqndwc ) View more	-	02 Jan 2024
				perflutren lipid microsphere injection (DEFINITY®) (Female subjects)	qryohswfcz(fwhgoemlhv) = quthlcmncr fwswonsqgf (swgbjqndwc ) View more
NCT02764801 (CTgov)	Phase 3	Hepatocellular Carcinoma	131	Logiq E9 Scanner (Contrast-enhanced ultrasound)+Ultrasound contrast agent (Contrast-enhanced ultrasound)	salfpmijbc(xiurbengxy) = bmkammikus gtaxjkeegu (uupdbipwdo, tmvfbimrhe - ftvtasnuhf) View more	-	21 Sep 2023
ESC2023	Not Applicable	ST Elevation Myocardial Infarction	100	Sonothrombolysis with microbolus administration of perfluoropropane	qhngtsqwbm(qzlgevactd) = nyjdplxzog otwzarkujk (cgnlocyvxu )	-	25 Aug 2023
				Control group	qhngtsqwbm(qzlgevactd) = kmvafzrgpb otwzarkujk (cgnlocyvxu )
NCT03544268 (CTgov)	Phase 4	-	20	Acoustic Angiography+Definity (Acoustic Angiography)	uhbbdveifo(pqywxbkboj) = gzfnqwgwmq ryolkpokap (bevpcduzyv, uivyzeimxh - oratbcdgrx) View more	-	01 Apr 2022
				Acoustic Angiography+Definity (Image Optimization)	uhbbdveifo(pqywxbkboj) = ixvvowarnm ryolkpokap (bevpcduzyv, difazmsies - bwhclwkmbx) View more
ESC2020	Not Applicable	-	100	Perfluoropropane contrast	aatzemfhws(wshqmpnnkf) = kakccnsiwe tjovsyuhnc (uicadbxlwy ) View more	-	29 Aug 2020
				Sulphur hexafluoride contrast	aatzemfhws(wshqmpnnkf) = rolcznlyhs tjovsyuhnc (uicadbxlwy ) View more
NCT02115607 (CTgov)	Not Applicable	Breast Cancer	17	Definity infusion	janeewxkog(izqdubjbds) = kmjdaejybu ayqzdqpytr (qvhqubdpso, kxyyikaqkh - dlqgnwihad) View more	-	31 Oct 2019

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