Improving radical resection rates in patients with breast cancer by intraoperative fluorescence imaging – the MARGIN-2 study

Phase 1

• Conditions: Female breast cancer patients with small tumor size in which breast conserving therapy is advised by the multidisciplinary tumor board.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-002804-19-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-25
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

To be eligible to participate in this study, the subject must meet all the following 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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
-Received neo-adjuvant therapy
-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 clinical trial of medicinal product
• Study Design: Not specified