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

Not Applicable

Recruiting

• Conditions: Breast Cancer Invasive; Breast Cancer
• Interventions: Procedure: Fluorescence guided detection of tumor positive margins.

• Registration Number: NCT05939310
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-11
• Study Start: 2024-01-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescence guided surgery	Fluorescence guided detection of tumor positive margins.	10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.

Primary Outcome Measures

Name	Time	Method
Detection	1 year	To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor margin.

Secondary Outcome Measures

Name	Time	Method
Radical resection rate	1 year	To analyze whether patients that in standard-of-care would have tumor-positive margins and needed additional treatment postoperatively, had a radical resection after biopsy using fluorescence guided surgery.
Detection in-vivo imaging	1 year	To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity.
Detection ex-vivo imaging	1 year	To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples.

Trial Locations

Locations (2)

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands