The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
* Complete two phases involving 6 visits
* Undergo additional research PET/CT, and possibly SPECT/CT scans

Start Date07 Mar 2025

Sponsor / Collaborator

University of Wisconsin Madison

NCT06016855

/ RecruitingPhase 4IIT

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs

Start Date31 May 2024

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

NCT05709171

/ Enrolling by invitationPhase 2IIT

Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms

Prospective clinical trial investigating combined, dual 18F-FDG PET/CT and 64Cu-DOTATATE PET/CT imaging of patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)

Start Date17 Jan 2023

Sponsor / Collaborator

Rigshospitalet

100 Clinical Results associated with Copper (64Cu) Oxodotreotide

100 Translational Medicine associated with Copper (64Cu) Oxodotreotide

100 Patents (Medical) associated with Copper (64Cu) Oxodotreotide

Literatures (Medical) associated with Copper (64Cu) Oxodotreotide

01 Nov 2024·JOURNAL OF NUCLEAR MEDICINE

Routine Use of [⁶⁴Cu]Cu-DOTATATE PET/CT in a Neuroendocrine Tumor Center: Referral Patterns and Image Results of 2,249 Consecutive Scans

Article

Author: Mortensen, Jann ; Kjaer, Andreas ; Langer, Seppo W ; Loft, Mathias ; Johnbeck, Camilla Bardram ; Enevoldsen, Lotte ; Knigge, Ulrich ; Oturai, Peter ; Carlsen, Esben Andreas

The role of somatostatin receptor (SSTR) PET/CT, using ⁶⁸Ga-based tracers or [⁶⁴Cu]Cu-DOTATATE (⁶⁴Cu-DOTATATE), in the management of patients with neuroendocrine neoplasm (NEN) is guided by appropriate use criteria (AUC). In this study, we performed systematic analyses of referral patterns and image findings of routine ⁶⁴Cu-DOTATATE PET/CT scans to support AUC development. Methods: We included all clinical routine ⁶⁴Cu-DOTATATE PET/CT scans performed between April 10, 2018 (start of clinical use), and May 2, 2022, at Copenhagen University Hospital-Rigshospitalet. We reviewed the referral text and image report of each scan and classified the indication according to clinical scenarios as listed in the AUC. Results: In total, 1,290 patients underwent 2,249 ⁶⁴Cu-DOTATATE PET/CT scans. Monitoring of patients with NEN seen both on conventional imaging and on SSTR PET without clinical evidence of progression was the most common indication (defined as "may be appropriate" in the AUC) and accounted for 703 (31.3%) scans. Initial staging after NEN diagnosis ("appropriate" in the AUC) and restaging after curative-intent surgery ("may be appropriate" in the AUC) accounted for 221 (9.8%) and 241 (10.7%) scans, respectively. Selection of patients eligible for peptide receptor radionuclide therapy ("appropriate" in the AUC) and restaging after peptide receptor radionuclide therapy completion ("appropriate" in the AUC) accounted for 95 (4.2%) and 115 (5.1%) scans, respectively. The number of scans performed for indications not defined in the AUC was 371 (16.5%). Image result analysis revealed no disease in 669 scans (29.7%), stable disease in 582 (25.9%), and progression in 461 (20.5%). In 99 of the 461 (21.5%) scans, progression was detected on PET but not on CT. Conclusion: Our study provided real-life data that may contribute to support development of ⁶⁴Cu-DOTATATE/SSTR PET/CT guidelines including AUC. Some scenarios listed as "may be appropriate" in the current AUC were frequent in our data. Monitoring of patients with NEN without clinical evidence of progression was the most frequent indication for ⁶⁴Cu-DOTATATE PET/CT, in which disease progression was detected in more than one third, and a large proportion was visible by PET only. We therefore conclude that this scenario could potentially be classified as appropriate.

01 May 2024·Nuclear medicine and biology

Investigation of imaging the somatostatin receptor by opening the blood-brain barrier with melittin – A feasibility study using positron emission tomography and [64Cu]Cu-DOTATATE

Article

Author: Strømgaard, Kristian ; Herth, Matthias M ; Gustavsson, Tobias ; Ingemann Jensen, Andreas T ; Kjær, Andreas ; Shalgunov, Vladimir ; Bidesi, Natasha Shalina Rajani ; Andersen, Ida Vang ; Jørgensen, Jesper Tranekjær

DOTATATE is a somatostatin peptide analog used in the clinic to detect somatostatin receptors which are highly expressed on neuroendocrine tumors. Somatostatin receptors are found naturally in the intestines, pancreas, lungs, and brain (mainly cortex). In vivo measurement of the somatostatin receptors in the cortex has been challenging because available tracers cannot cross the blood-brain barrier (BBB) due to their intrinsic polarity. A peptide called melittin, a main component of honeybee venom, has been shown to disrupt plasma membranes and increase the permeability of biological membranes. In this study, we assessed the feasibility of using melittin to facilitate the passage of [⁶⁴Cu]Cu-DOTATATE through the BBB and its binding to somatostatin receptors in the cortex. Evaluation included in vitro autoradiography on Long Evans rat brains to estimate the binding affinity of [⁶⁴Cu]Cu-DOTATATE to the somatostatin receptors in the cortex and an in vivo evaluation of [⁶⁴Cu]Cu-DOTATATE binding in NMRI mice after injection of melittin. This study found an in vitro B_max = 89 ± 4 nM and K_D = 4.5 ± 0.6 nM in the cortex, resulting in a theoretical binding potential (BP) calculated as B_max/K_D ≈ 20, which is believed suitable for in vivo brain PET imaging. However, the in vivo results showed no significant difference between the control and melittin injected mice, indicating that the honeybee venom failed to open the BBB. Additional experiments, potentially involving faster injection rates are required to verify that melittin can increase brain uptake of non-BBB permeable PET tracers. Furthermore, an evaluation of whether a venom with a narrow therapeutic range can be used for clinical purposes needs to be considered.

01 May 2024·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Verma, Sant Kumar ; Navneesh, N ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

News (Medical) associated with Copper (64Cu) Oxodotreotide

15 Nov 2022

·www.biospace.com

RadioMedix and Vect-Horus announce first dosing of Glioblastoma Multiforme and Pancreatic ductal adenocarcinoma patients with 68Ga-RMX-VH

Houston, TX, USA and Marseille, France, Nov. 15, 2022 (GLOBE NEWSWIRE) -- RadioMedix and Vect-Horus are pleased to announce that they have successfully dosed the first patients in an exploratory Investigational New Drug (eIND) application to evaluate 68Ga-RMX-VH for the diagnostic of Glioblastoma Multiforme (GBM) and Pancreatic ductal adenocarcinoma (PDAC). This radiotracer will serve as a companion diagnostic for future Targeted Alpha Therapy (TAT) for these cancers. 68Ga-RMX-VH is a positron-emitting tomography (PET) agent that targets the Low-Density Lipoprotein Receptor (LDLR) overexpressed in some solid tumors such as GBM and PDAC. The objective of this exploratory study is to evaluate the safety, dosimetry, and bio-distribution of 68Ga-RMX-VH in patients with solid tumors. GBM is the most common malignant primary brain tumor in adults and is a serious and life-threatening disease. PDAC is one of the most chemo-resistant and radio-resistant types of cancers due to the dense pancreatic connective tissue and the diversity of genetic mutations. RadioMedix and Vect-Horus have already signed a co-development and a licensing agreement. Both parties will share the costs of development until Phase 1 for diagnostic and radiotherapy. RadioMedix is leading the clinical development and future commercialization. “Both GBM and PDAC are considered among the most aggressive human cancers. Our current therapeutic approaches for these cancers are invasive and fail meaningful results while adversely effects on the quality of life of our patients. Our approach starts with PET/CT imaging of the diagnostic version of the drug to confirm adequate targeting of the cancers and then applying a therapeutic version of the drug to mainly target the malignant cells while sparing normal organs. All these are accomplished with simple intravenous administration of the drugs.” said Dr Ebrahim Delpassand, Chairman and CEO of RadioMedix. “Another complexity of treating GBM is being able to deliver the drug to the tumor by crossing the blood-brain barrier. Our preliminary results suggest that RMX-VH ligand can accomplish this task”. Added Dr. Delpassand “The favorable results of the first PET/CT imaging scans of GBM and PDAC patients are the culmination of the extensive pre-clinical studies done by RadioMedix and Vect-Horus teams. RadioMedix is serving as a Sponsor and manufacturer of the clinical doses of 68Ga-RMX-VH.”, said Dr. Izabela Tworowska, CSO of RadioMedix. “Our company has a track record in the translation of radiotheranostics drugs, and we are committed to improving diagnosis and therapy of GBM and PDAC", added Dr. Tworowska. “We are excited to have successfully treated the first patients with 68Ga-RMX-VH. The preclinical and preliminary clinical data to date indicates potential diagnostic of this agent and we look forward to generating further evidence as we progress” said Dr. Temsamani, Director of Drug Development of Vect-Horus. “The initiation of this clinical trial is an important milestone for Vect-Horus as it marks the initiation of the clinical program of the imaging candidate, 68Ga-RMX-VH and our transition to a clinical-stage Company. We are looking forward to generating clinical data together with our partner RadioMedix with the aim of improving both diagnostic and therapy for cancer patients and addressing this significant unmet medical need,” said Alexandre Tokay, CEO of Vect-Horus. About RadioMedix RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for the diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company’s first diagnostic product 64Cu-DOTATATE (Detectnet®) was approved by US FDA in September 2020. RadioMedix is also sponsoring a phase II clinical trial for the treatment of metastatic or inoperable neuroendocrine cancer using 212Pb-DOTAMTATE (AlphaMedix™) Targeted Alpha-Therapy (TAT) with promising results. In addressing other unmet needs in oncology, RadioMedix is developing theranostic agents to treat brain tumors, and pancreatic ductal adenocarcinoma (PDAC). In addition, RadioMedix has established contract service facilities for academic and industrial partners, including a drug discovery center for the early probe development, a Pre-clinical core facility for in vitro and in vivo evaluation of radiopharmaceuticals, and cGMP and analytical suite for Phase I-III clinical trials, and the large-scale post-approval commercial manufacturing facility, at its Spica Center, in Humble, Texas. To learn more, visit . For more information about this press release, please contact media@radiomedix.com. About Vect-Horus Vect-Horus develops vectors that facilitate the targeting of therapeutic or imaging agents to organs. Vect-Horus combines these different agents to its vectors that specifically target various receptors, allowing these agents to cross cellular barriers, that limit their access to their targets. The proof of concept of the technology has already been established in animal models using different vectorized molecules. Created in 2005, Vect-Horus is a spin-off of the Institute for Neurophysiopathology (UMR7051, CNRS and Aix Marseille University), headed by Dr. Michel Khrestchatisky, co-founder. To learn more, visit For more information about this press release, please contact contact@vect-horus.com. Izabela Tworowska, PhD CSO, RadioMedix Inc itworowska@radiomedix.com

License out/inPhase 2

07 Oct 2022

·www.biospace.com

RadioMedix announces a $40 million Series A financing for the advancement of novel Targeted Alpha Therapy platform and diagnostic companion radiopharmaceuticals to address unmet needs in oncology;

Michael Lee-Chin appointed to the board of the company HOUSTON and BURLINGTON, Ontario, Oct. 07, 2022 (GLOBE NEWSWIRE) -- RadioMedix, Inc. (“RadioMedix” or “Company”), a clinical-stage biotechnology company announced an agreement with an entity related to Portland Investment Counsel Inc. (“Portland”) involving an equity investment of $40 million Series A funding round. RadioMedix is committed to the advancement of a targeted alpha therapy (TAT) pipeline and diagnostic companion radiopharmaceuticals for rare and aggressive cancers. The proceeds of the financing will be applied to developing RadioMedix’s flagship radiopharmaceutical AlphaMedix™, a lead-212 (Pb212) labelled somatostatin analogue TAT agent for the treatment of metastatic or inoperable somatostatin expressing neuroendocrine tumors, in addition to other diagnostic and therapeutic (theranostic) radiopharmaceuticals that are under development by the Company to address needs in oncology. The initiation of the AlphaMedix™ Phase II clinical trial in the last quarter of 2021, a vital milestone in the clinical development of RadioMedix’s innovative TAT, has brought significant hope to patients across the globe suffering from this illness. “We are living in an exciting time with the treatment of difficult cancers. Targeted radionuclide therapy with beta and alpha emitters and specific radiopharmaceutical diagnostic probes are among the most innovative emerging technologies available to us. This funding will accelerate our efforts to make several of these medications available to our patients,” said Dr. Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix. RadioMedix will appoint Mr. Michael Lee-Chin to the Company’s board of directors. Mr. Lee-Chin is the founder, CEO and Executive Chairman of Portland, and brings over 40 years of investment experience with a successful track record in the industry. “Mr. Lee-Chin and the Portland team bring a unique combination of financial and organizational expertise in addition to a strategic network to RadioMedix. This will be pivotal for our Company to achieve its goal of moving our drugs from bench to commercialization and make them available globally to all patients suffering from cancer. I am confident that in collaboration with our other board members, Mr. Lee-Chin will play a pivotal role in our strategic thinking and the shaping of the future of RadioMedix in the promising field of theranostic and targeted radionuclide therapy,” continued Dr. Delpassand. “I am thrilled and humbled to join the RadioMedix board of directors. I look forward to the opportunity to contribute to RadioMedix’s vision and mission of addressing one of humankind’s most challenging problems – seeking a cure for cancer. Portland’s mantra of “Doing Well by Doing Good” is aligned with RadioMedix’s goal of providing cancer patients with better outcomes,” said Mr. Lee-Chin. “Targeted alpha therapies are currently considered one of the most advanced technologies available to treat patients with incurable cancers. The clinical pathway and platform of novel and effective radiopharmaceuticals developed by Dr. Delpassand and his team should significantly impact cancer treatments globally. Portland and RadioMedix have aligned their complementary capabilities and are united by a commitment to help others,” added Mr. Lee-Chin. About RadioMedix RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for the diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labelled agents). The company’s first diagnostic product 64Cu-DOTATATE (Detectnet®) was approved by US FDA in September of 2020. RadioMedix is also sponsoring a phase II clinical trial for treatment of metastatic or inoperable neuroendocrine cancer using 212Pb-DOTAMTATE (AlphaMedix™) Targeted Alpha-Therapy (TAT) with promising results. In addressing other unmet needs in oncology, RadioMedix is developing theranostic agents to treat brain tumors, and pancreatic ductal adenocarcinoma (PDAC). In addition, RadioMedix has established contract service facilities for academic and industrial partners, including a drug discovery center for the early probe development, a pre-clinical core facility for in vitro and in vivo evaluation of radiopharmaceuticals, and cGMP and analytical suite for Phase I-III clinical trials, and the large-scale post-approval commercial manufacturing facility, at its Spica Center, in Humble, Texas. To learn more, visit About Portland Investment Counsel Inc. Headquartered in Canada, Portland Investment Counsel Inc. is part of Portland Holdings group of companies, which invest in public and private equities. Portland Holdings, a privately held group of investment companies, have an ownership interest in a collection of diversified businesses operating in sectors that include financial services, insurance, tourism, agriculture, consumer goods and services, real estate development, energy and targeted radionuclide therapy. The Wealthy Invest Differently. Portland understands this and has made it their mission to provide all wealth-seeking investors with access to investment opportunities both within the public and private realm typically reserved for affluent and institutional investors. Portland invests in private equity, private debt, publicly traded equities and fixed income securities globally on behalf of retail and institutional clients. RadioMedix, Inc. Contact Brittney Stewart Manager, Media Liaison and public awareness Phone: 713-341-3219 Email: bstewart@radiomedix.com Portland Holdings Contact Diana N. Oddi Director, Marketing and Communications 1-888-331-4292 Email: doddi@portlandholdings.com

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100 Deals associated with Copper (64Cu) Oxodotreotide

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KEGG	Wiki	ATC	Drug Bank
D11882	-	L01XX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuroendocrine Tumors	United States	Curium US Holdings LLC	03 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	United States	RadioMedix, Inc.	23 Aug 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	Endocarditis, Bacterial	-	64Cu-DOTATATE PET/CT	mevfczqbtv(ooajwrlffi) = rqzrzlutpc ivscwlugax (arfcejdvwv ) View more	-	01 Sep 2024
ASCO2024	Not Applicable	Neuroendocrine Tumors	-	Cu64-dotatate-PET/CT	addvpsnwyd(jkddovsptq) = zehllrkybu bykkwuehiy (nkbanvangu ) View more	-	24 May 2024
ASCO2024	Not Applicable	Neuroendocrine Tumors	-	Ga68-dotatate-PET/CT	addvpsnwyd(jkddovsptq) = ecybvxevvw bykkwuehiy (nkbanvangu ) View more	-	24 May 2024
NCT03673943 (CTgov)	Phase 3	Somatostatin Receptor-Positive Neuroendocrine Tumor	63	64Cu-DOTATATE	yyjbdmlbci = bmhycqtivp atedebkaxs (dcumpvzqty, anqckspzib - jvutkavpbs) View more	-	22 Dec 2022
NCT03673943 (Pubmed \| J Nucl Med) Manual	Phase 3	Somatostatinoma Somatostatin Receptor-Positive	12	64 Cu-DOTATATE	udcqxkaoqe(jdkeaisryg) = yorpmkxryl gqnqmprnzc (fiskgvziqr ) View more	Positive	01 Jun 2020
SNMMI2016	Not Applicable	Neuroendocrine Tumors	-	64Cu-DOTATATE	lhpezsscjs(fyhteqhdqi) = stvcgyhjnn ffpcdlnhlf (telydbtntp ) View more	-	24 May 2016
SNMMI2016	Not Applicable	Neuroendocrine Tumors	-	68Ga-DOTATOC	lhpezsscjs(fyhteqhdqi) = magulyvllw ffpcdlnhlf (telydbtntp ) View more	-	24 May 2016

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