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Trial Title:
Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study
NCT ID:
NCT05939310
Condition:
Breast Cancer
Breast Cancer Invasive
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Fluorescence guided detection of tumor positive margins.
Description:
Intraoperative fluorescence imaging detection of tumor positive margins using the
targeted tracer bevacizumab-IRDye800CW.
Arm group label:
Fluorescence guided surgery
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Pieter J van der Zaag
Phone:
+31 50 3616161
Email:
p.j.van.der.zaag@umcg.nl
Facility:
Name:
Martini Ziekenhuis
Address:
City:
Groningen
Zip:
9728NT
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Wendy Kelder
Phone:
+31 50 5245245
Email:
w.kelder@mzh.nl
Start date:
January 1, 2024
Completion date:
December 30, 2024
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Collaborator:
Agency:
Martini Hospital Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05939310
