Fluorescence Guided Surgery in Breast Cancer

Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02583568

Acronym

MARGIN

Enrollment

Registered

2015-10-22

Start date

2015-10-31

Completion date

2017-02-28

Last updated

2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, image-guided surgery

Brief summary

A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.

Interventions

DRUGBevacizumab-800CW

three days prior to surgery bevacizumab-800CW will be administered

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: 1. Females aged ≥ 18 years. 2. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery. 3. Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data. 4. WHO performance score 0-2. 5. Life expectancy greater than 12 weeks 6. Written informed consent has been obtained 7. In the Investigator's opinion, patient is able and willing to comply with all trial requirements. For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: 8. A negative serum pregnancy test prior to receiving the second generation tracer 9. Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Main

Exclusion criteria

1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent 2. Breast prosthesis in the target breast 3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies 4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment 5. Significant renal or hepatic impairment. 6. Inadequately controlled hypertension with or without current antihypertensive medications. 7. History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment. 8. Patients receiving anticoagulant therapy with vitamin K antagonists. 9. Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents. 10. Evidence of QT prolongation on pre-treatment ECG (Males \>440 ms, Females \>450 ms). 11. Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.

Design outcomes

Primary

Measure	Time frame
Tumor-to-background ratio	day 3

Secondary

Measure	Time frame
Number of participants with treatment-related adverse events	up to two weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026