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Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study | Clinical Trials | Clareo Health

RECRUITINGNA

Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study

Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study

NCT05939310•University Medical Center Groningen

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to intraoperatively visualize tumour tissue in breast cancer patients using fluorescence imaging with the tracer bevacizumab-IRDye800CW and thereby enhance real-time clinical decision making, preventing postoperative tumour-positive margins.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients are females with histologically proven carcinoma of the breast
•The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised.
•Age ≥ 18 years
•Written informed consent has been obtained
•Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Exclusion Criteria

•Medical or psychiatric conditions that compromise the patient's ability to give informed consent
•Non palpable breast tumor or prior surgery of this breast
•Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW
•History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment
•Inadequately controlled hypertension with or without current antihypertensive medication
•Significant renal or hepatic impairment (grade II or higher deviations by CTCAE)
•History of allergy or infusion reactions bevacizumab or other monoclonal antibodies
•Pregnant or lactating women
•Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
•Life expectancy \< 12 weeks
+1 more criteria

Locations (2)

University Medical Center Groningen

Groningen, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Key Dates

Start Date

January 1, 2024

Primary Completion Date

September 30, 2024

Completion Date

December 30, 2024

Last Updated

April 19, 2024

Enrollment

ESTIMATED participants

Conditions

Breast CancerBreast Cancer Invasive

Interventions

Fluorescence guided detection of tumor positive margins.

PROCEDURE

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RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer