Fluorescence Guided Surgery in Breast Cancer

Breast Cancer Clinical Trial

— MARGIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583568
• Other study ID #: NL52447.042.15
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 30, 2015
• Last updated: February 10, 2017
• Start date: October 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered

Locations

Country	Name	City	State
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	Tumor-to-background ratio		day 3
Secondary	Number of participants with treatment-related adverse events		up to two weeks