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

NCT05939310 | Recruiting

• 1 other identifier: 10975
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Detection

  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.

  1 year

Secondary Outcomes (3)

• Detection ex-vivo imaging

  1 year

• Detection in-vivo imaging

  1 year

• Radical resection rate

  1 year

Study Arms (1)

Fluorescence guided surgery

EXPERIMENTAL

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

Procedure: Fluorescence guided detection of tumor positive margins.

Interventions

Fluorescence guided detection of tumor positive margins. PROCEDURE

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

Fluorescence guided surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Martini Hospital Groningen: collaborator

Study Sites (2)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, 9728NT, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (2)