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

NCT ID: NCT05939310

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-30

Brief 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.

Conditions

Breast Cancer; Breast Cancer Invasive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fluorescence guided surgery

10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.

Group Type: EXPERIMENTAL

Fluorescence guided detection of tumor positive margins.

Intervention Type: PROCEDURE

Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW.

Interventions

Fluorescence guided detection of tumor positive margins.

Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW.

Intervention Type: PROCEDURE

Eligibility Criteria

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
• Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Martini Hospital Groningen

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Martini Ziekenhuis

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Pieter J van der Zaag

Role: primary

p.j.van.der.zaag@umcg.nl

+31 50 3616161

Wendy Kelder

Role: primary

w.kelder@mzh.nl

+31 50 5245245

Other Identifiers

10975

Identifier Type: -

Identifier Source: org_study_id