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

Breast Cancer Clinical Trial

— MARGIN-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939310
• Other study ID #: 10975
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Invasive
• Breast Neoplasms

Intervention

Procedure:
• Fluorescence guided detection of tumor positive margins.
Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW.

Locations

Country	Name	City	State
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection ex-vivo imaging	To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples.	1 year
Secondary	Detection in-vivo imaging	To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity.	1 year
Secondary	Radical resection rate	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.	1 year