Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

Start Date01 Jan 2026

Sponsor / Collaborator

Lumicell, Inc.

NCT04440982

/ TerminatedPhase 2

Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy

This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

Start Date01 Sep 2020

Sponsor / Collaborator

Lumicell, Inc.

[+1]

NCT03686215

/ CompletedPhase 3

Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins.
All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Start Date04 Nov 2019

Sponsor / Collaborator

Lumicell, Inc.

[+1]

100 Clinical Results associated with Pegulicianine

100 Translational Medicine associated with Pegulicianine

100 Patents (Medical) associated with Pegulicianine

Literatures (Medical) associated with Pegulicianine

27 Jun 2023·NEJM evidence

Something to Dye For: Toward Better Breast Lumpectomy Margins

Author: Shriver, Craig D. ; Turza, Lauren C.

The development of fluorescence imaging in oncology led to the possibility of using intraoperative devices to improve the precision of surgical techniques.¹ In this issue of NEJM Evidence, Smith et al.² report results from a prospective multicenter trial evaluating the ability of intravenous pegulicianine with an optical head device and software to intraoperatively identify lumpectomy margins with residual cancer and excise them immediately. Identifying these margins intraoperatively avoids the need for a second surgery, which is required when margins are positive on the final pathology.

27 Jun 2023·NEJM evidence

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery

Article

Author: Dekhne, Nayana ; Stone, Kimberly ; Schlossberg, Brian ; Lee, Marie Catherine ; Hunt, Kelly K. ; Hwang, E. Shelley ; Blumencranz, Peter W. ; Lesnikoski, Beth-Anne ; Smith, Barbara L. ; Clark, Patricia ; Clark, Lynne ; Ferrer, Jorge ; Wapnir, Irene L. ; Gadd, Michele A. ; Carr, David ; Harris, Daniel K. ; Dodge, Daleela ; Valente, Stephanie ; Dyess, Donna L. ; Samiian, Laila ; Chang, Manna ; Smith, Kate Porta

BACKGROUND: Although lumpectomy and mastectomy provide equivalent survival for patients with breast cancer, local recurrence after lumpectomy increases breast cancer mortality. Positive lumpectomy margins, which imply incomplete tumor removal, are the strongest predictor of local recurrence and are identified days after surgery, necessitating a second surgery. METHODS: In this prospective trial, we assessed margin status with or without pegulicianine fluorescence-guided surgery (pFGS) for stages 0 to 3 breast cancers. To prevent surgeons from performing smaller than standard lumpectomies in anticipation of pFGS assistance, patients were randomly assigned 10:1 to pFGS or control groups, thus randomization was not designed to provide a control group for evaluating device performance. In patients undergoing pFGS, additional pFGS-guided cavity margins were excised at sites of pegulicianine signal. We evaluated three coprimary end points: the percentage of patients for whom pFGS-guided margins contained cancer, sensitivity, and specificity. RESULTS: Overall, 406 patients received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Among 392 patients randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. In 27 of 357 patients undergoing pFGS, pFGS-guided margins removed tumor left behind after standard lumpectomy, 22 from cavity orientations deemed negative on standard margin evaluation. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins. On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. Pegulicianine administration was stopped for adverse events in six patients. Two patients had grade 3 serious adverse events related to pegulicianine. CONCLUSIONS: The use of pFGS in breast cancer surgery met prespecified thresholds for removal of residual tumor and specificity but did not meet the prespecified threshold for sensitivity. (Funded by Lumicell, Inc. and the National Institutes of Health; Clinicaltrials.gov number, NCT03686215.)

01 Jul 2022·JAMA surgery

Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence–Guided System

Article

Author: Lesnikoski, Beth-Ann ; Gold, Linsey ; Dekhne, Nayana ; Madden, Sean ; Lee, David ; Harris, Daniel K ; Smith, Kate ; Dodge, Daleela ; Beitsch, Peter ; Ferrer, Jorge ; Hunt, Kelly ; Hwang, E. Shelley ; Karp, Stephen ; Wapnir, Irene ; Grobmyer, Stephen ; Chang, Manna ; Carr, David ; Clark, Lynne ; Schlossberg, Brian ; Dyess, Donna L. ; Blumencranz, Peter ; Chagpar, Anees ; Strasfeld, David ; Smith, Barbara L.

Importance:

Positive margins following breast-conserving surgery (BCS) are often identified on standard pathology evaluation. Intraoperative assessment of the lumpectomy cavity has the potential to reduce residual disease or reexcision rate following standard of care BCS in real time.

Objective:

To collect safety and initial efficacy data on the novel pegulicianine fluorescence-guided system (pFGS) when used to identify residual cancer in the tumor bed of female patients undergoing BCS.

Design, Setting, and Participants:

This prospective single-arm open-label study was conducted as a nonrandomized multicenter controlled trial at 16 academic or community breast centers across the US. Female patients 18 years and older with newly diagnosed primary invasive breast cancer or ductal carcinoma in situ DCIS undergoing BCS were included, excluding those with previous breast cancer surgery and a history of dye allergies. Of 283 consecutive eligible patients recruited, 234 received a pegulicianine injection and were included in the safety analysis; of these, 230 were included in the efficacy analysis. Patients were enrolled between February 6, 2018, and April 10, 2020, and monitored for a 30-day follow-up period. Data were analyzed from April 10, 2020, to August 5, 2021.

Interventions:

Participants received an injection of a novel imaging agent (pegulicianine) a mean (SD) of 3.2 (0.9) hours prior to surgery at a dose of 1 mg/kg. After completing standard of care (SOC) excision, pFGS was used to scan the lumpectomy cavity to guide the removal of additional shave margins.

Main Outcomes and Measures:

Adverse events and sensitivity, specificity, and reexcision rate.

Results:

Of 234 female patients enrolled (median [IQR] age, 62.0 [55.0-69.0] years), 230 completed the trial and 1 patient with a history of allergy to contrast agents had an anaphylactic reaction and recovered without sequelae. Correlation of pFGS with final margin status on a per-margin analysis showed a marked improvement in sensitivity over standard pathology assessment of the main lumpectomy specimen (69.4% vs 38.2%, respectively). On a per-patient level, the false-negative rate of pFGS was 23.7% (9 of 38), and sensitivity was 76.3% (29 of 38). Among 32 patients who underwent excision of pFGS-guided shaves, pFGS averted the need for reexcision in 6 (19%).

Conclusions and Relevance:

In this pilot feasibility study, the safety profile of pegulicianine was consistent with other imaging agents used in BCS, and was associated with a reduced need for second surgery in patients who underwent intraoperative additional excision of pFGS-guided shaves. These findings support further development and clinical performance assessment of pFGS in a prospective randomized trial.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03321929.

News (Medical) associated with Pegulicianine

13 Dec 2024

·www.prnewswire.com

Lumicell Announces Poster Presentations at the 2024 San Antonio Breast Cancer Symposium Focused on Patient Benefit of Using LumiSystem™ During Lumpectomy

New data suggests that patients were satisfied with their cosmetic outcomes following the removal of suspicious tissue detected by fluorescence-guided imaging during lumpectomy surgery, and prefer to avoid a second surgeryAdding LumiSystem to a lumpectomy procedure may lead to a reduction in targeted volume of radiation therapy for some patients and may lead to the option to omit radiation in other patients NEWTON, Mass., Dec. 13, 2024 /PRNewswire/ -- Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, presented posters demonstrating patient benefit of use with LumiSystem during the 2024 San Antonio Breast Cancer Symposium® (SABCS®) from Dec 10-13. Continue Reading LUMISIGHT™ (pegulicianine) is approved for use as an optical imaging agent in combination with Lumicell™ Direct Visualization System (DVS) to detect cancerous tissue within the breast cavity as an adjunct during the lumpectomy procedure. LumiSystem is the combination of these two FDA-approved products. "The patient survey feedback about the use of LumiSystem during their lumpectomy procedures has been very positive." Post this "The patient survey feedback about the use of LumiSystem during their lumpectomy procedures has been very positive," said Howard Hechler, CEO, Lumicell. "We're excited to share these insights with providers so that their patients may be able to avoid a second surgery or minimize radiation, potentially improving the patient experience and outcomes." Poster Presentation Highlights Presentation title: Does additional margin excision during LumiSystem (pegulicianine) fluorescence-guided lumpectomy surgery affect patient breast satisfaction? Presenting author: Barbara Smith, M.D. Poster number: P3-09-04 Key points : Post-operative breast satisfaction surveys were completed 6-12 months after surgery No significant difference in mean post-operative breast satisfaction scores between device and control arm patients (78.2 out of 100 for control arm patients versus 79.8 out of 100 for device arm patients, p = 0.359) 70.6% of surveyed participants strongly preferred or preferred avoiding a second surgery compared to optimizing cosmetic outcomes This analysis was limited by its small sample size due to enrollment ending early. Presentation title : LumiSystem-guided lumpectomy enables informed customization of radiation therapy in select patients with breast cancer. Presenting author: Simona Shaitelman, M.D. Poster number: P5-09-13 Key points : 357 patients received LumiSystem-guided surgery, and a retrospective review was performed to evaluate patient eligibility for de-escalation or omission of radiotherapy Among patients who were eligible for omission of radiotherapy after standard of care negative margins, LumiSystem-guided excisions resulted in removal of unsuspected residual tumor. LumiSystem-guided wider negative margins (compared to standard of care procedures) led to the potential of a reduced targeting volume of radiation therapy and the option to omit radiation in some patients. Healthcare providers are encouraged to contact 1-833-4LUMDVS for any questions about LUMISIGHT or Lumicell DVS. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company's lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are approved for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell's proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit and follow the company on Facebook, X, and LinkedIn. Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. IMPORTANT SAFETY INFORMATION What is LUMISIGHT (pegulicianine) and Lumicell DVS? LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure. What is the most important information I should know about LUMISIGHT? Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during the use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. What additional important information should I know about LUMISIGHT and Lumicell DVS? Adjunctive Use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT. Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information visit . Rx only MKT00317rA Media Inquiries: [email protected] SOURCE Lumicell, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiation TherapyDrug Approval

05 Sep 2024

·www.businesswire.com

CMS Grants Transitional Pass-Through Payment for LUMISIGHT™ (pegulicianine) and Increases Access for Patients with Breast Cancer

NEWTON, Mass.--( BUSINESS WIRE )-- Lumicell, Inc ., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved its application for transitional pass-through (TPT) status for LUMISIGHT™ (pegulicianine) under the Medicare hospital outpatient prospective payment system (OPPS). The new Healthcare Common Procedure Coding System (HCPCS) drug TPT code (C9171 Injection, pegulicianine, 1 mg) may be used to bill CMS for LUMISIGHT when it is used in the treatment of Medicare beneficiaries in the hospital outpatient setting starting October 1, 2024. The TPT payment is a mechanism created by the CMS to increase patient access to new and truly innovative technologies, such as LUMISIGHT, by facilitating adequate payment of new technologies. TPT will provide additional Medicare payment for LUMISIGHT for 2 to 3 years, and during this time, Medicare will collect and assess the data in consideration of future payments. “We are proud that the country's largest payer for health care recognizes the importance of our truly innovative fluorescence-guided imaging technology," said Howard Hechler, President and COO, “enhancing patient access to LUMISIGHT while helping surgeons to find cancer that might otherwise go undetected.” Up to 36% of patients with breast cancer have follow-up surgeries due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining according to clinical studies. 1 When LUMISIGHT is used with Lumicell DVS during lumpectomy, together referred to as LumiSystem™, surgeons can detect and resect residual breast cancer with 84% diagnostic accuracy as an adjunct to the procedure. 2 LUMISIGHT (pegulicianine) received FDA approval in April of 2024 and will be commercially available in Q4 of this year. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the standard of care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook , X , and LinkedIn . Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Important Safety Information What is LUMISIGHT (pegulicianine) and Lumicell DVS? LUMISIGHT (pegulicianine), an optical fluorescence imaging agent, and Lumicell DVS, an imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure. What is the most important information I should know about LUMISIGHT? Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. What are the most common side effects of LUMISIGHT? The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information , including Boxed Warning. What additional important information I should know about LUMISIGHT and Lumicell DVS? Adjunctive use : Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT. Tissue perforation or damage : During the procedure, your healthcare provider should avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk : To avoid infection risk, the reusable Lumicell DVS handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort : Your healthcare provider should avoid direct eye exposure to Lumicell DVS handheld light probe as it may cause pain. Please see the LUMISIGHT Prescribing Information , including Boxed Warning, and Lumicell DVS Instructions for Use . For complete product information, visit www.LumiSystem.com . 1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et al., NEJM Evidence 2023; 2(7) MKT00267rA

Drug Approval

15 Jul 2024

·www.businesswire.com

Lumicell Announces New Category III CPT® Code for Intraoperative Fluorescence Imaging Margin Assessment in Support of Market Launch

NEWTON, Mass.--( BUSINESS WIRE )-- Lumicell, Inc ., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the American Medical Association has granted a Category III, Current Procedural Terminology (CPT) add-on code 0945T specifically for intraoperative fluorescence imaging margin assessment following breast cancer lumpectomy. 3 The new CPT code is expected to become effective on Jan. 1, 2025. The purpose of CPT coding is to provide a uniform language that accurately describes medical, diagnostic, and testing services for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties such as payors. The granting of this add-on code will allow physicians to report their usage of LUMISIGHT™ and Lumicell™ DVS, together referred to as LumiSystem™, to help payors collect claims data for improved access. “This is an important milestone for providers who offer this new adjunctive treatment option to their patients with breast cancer undergoing lumpectomy,” said Howard Hechler, President and Chief Operating Officer, Lumicell. “The Category III code will enable wider commercial access to LumiSystem by facilitating future reimbursement from US government payors and commercial health insurance companies.” Clinical studies have shown that up to 36% of patients have re-excisions due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining. 1 With 84% diagnostic accuracy, LumiSystem is the first and only system that enables surgeons to scan inside the breast cavity, in real-time, to detect and resect residual cancer that may have otherwise been left behind. 2 “This new CPT code demonstrates positive momentum towards improving patient access to LumiSystem, which will have significant impact on breast cancer surgical outcomes for patients,” said Peter Blumencranz, MD, Medical Director, BayCare Oncology Service Line and The Comprehensive Breast Care Center of Tampa Bay. LumiSystem will be commercially available in Q4 of this year. Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook , X , and LinkedIn . Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Important Safety Information What is the most important information I should know about LUMISIGHT? LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. What other safety information should I know about LUMISIGHT? Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. What are the most common side effects of LUMISIGHT? The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information , including Boxed Warning. What is the most important information I should know about Lumicell DVS? Adjunctive use : Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. Tissue perforation or damage : During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk : To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort : Avoid direct eye exposure to handheld light probe as it may cause pain. Please see the LUMISIGHT Prescribing Information , including Boxed Warning, and Lumicell DVS Instructions for Use . For complete product information, visit www.LumiSystem.com . © 2024 Lumicell Inc. All Rights Reserved. MKT00246 1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et al., NEJM Evidence 2023; 2(7) 3 https://www-ama-assn-org.libproxy1.nus.edu.sg/system/files/cpt-category3-codes-long-descriptors.pdf

100 Deals associated with Pegulicianine

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	United States	Lumicell, Inc.	17 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Invasive Mammary Carcinoma	Phase 2	United States	Lumicell, Inc.	01 Sep 2020
Adenocarcinoma of prostate	Phase 2	United States	Lumicell, Inc.	20 Mar 2019
Secondary malignant neoplasm of peritoneum	Phase 2	United States	Lumicell, Inc.	18 Mar 2019
Colorectal Cancer	Phase 2	United States	Lumicell, Inc.	04 Aug 2016
Early gastric cancer	Phase 2	United States	Lumicell, Inc.	04 Aug 2016
Esophageal Carcinoma	Phase 2	United States	Lumicell, Inc.	04 Aug 2016
Pancreatic Cancer	Phase 2	United States	Lumicell, Inc.	04 Aug 2016
Brain metastases	Clinical	United States	Lumicell, Inc.	03 May 2019
Glioblastoma	Clinical	United States	Lumicell, Inc.	03 May 2019
IDH1-mutant Glioma	Clinical	United States	Lumicell, Inc.	03 May 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03686215 (CL0007, FDA_CDER) Manual	Phase 3	Breast Cancer	357	LUMISIGHT	ntubnwxpba(julmnvykql) = sdxafoodlu gggceekjpr (bovjbaioss, 5.0 - 10.8) View more	Positive	17 Apr 2024
NCT03686215 (pivotal study \| CL0007 \| INSITE, CTgov)	Phase 3	Breast Cancer	406	Study Device Arm (Device Intervention: LUM Imaging System Used During Surgery)	gcwexyezyc = kjkkncvsvt qxhxtawjdv (xtadhkqwsm, usmqmampim - mcltfqawse) View more	-	24 Aug 2023
				LUM015 (Standard of Care Arm)	wcufllwgox(svkwfenvdu) = lffwtbpllh xrolilqyoy (vfvbmicvst, mvdtmhhvtj - taodxbjfiw) View more
NCT02438358 (CTgov)	Phase 1/2	Breast Cancer	60	LUM015 (Phase A No LUM015)	qqndmrampl(genferbwqh) = dpzbtwftjp ggldadysry (vgzzzjxpqv, 0.7)	-	05 Jan 2023
				LUM015 (Phase A 0.5 mg/kg)	qqndmrampl(genferbwqh) = ezzkilrcyb ggldadysry (vgzzzjxpqv, 2.0)
NCT01626066 (ASCO2014)	Phase 1	Neoplasms	9	LUM015 0.25 mg/kg	sdemyjadba(yexksaxkdk) = jyrkvbzuze pacuiemnvd (xrkhrdvqze )	-	20 May 2014
				LUM015 0.5 mg/kg	sdemyjadba(yexksaxkdk) = bkxpiqkfyp pacuiemnvd (xrkhrdvqze )

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