Fluorescence Guided Surgery in Breast Cancer (MARGIN)
February 10, 2017 updated by: G.M. van Dam, University Medical Center Groningen
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9713 GZ
- University Medical Center Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Main Inclusion Criteria:
- Females aged ≥ 18 years.
- Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
- Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
- WHO performance score 0-2.
- Life expectancy greater than 12 weeks
- Written informed consent has been obtained
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:
- A negative serum pregnancy test prior to receiving the second generation tracer
- Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Main Exclusion Criteria:
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Breast prosthesis in the target breast
- History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
- Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
- Significant renal or hepatic impairment.
- Inadequately controlled hypertension with or without current antihypertensive medications.
- 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.
- Patients receiving anticoagulant therapy with vitamin K antagonists.
- Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
- Evidence of QT prolongation on pre-treatment ECG (Males >440 ms, Females >450 ms).
- Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part 1
In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
|
three days prior to surgery bevacizumab-800CW will be administered
Other Names:
|
|
Experimental: Part 2
In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group.
|
three days prior to surgery bevacizumab-800CW will be administered
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Tumor-to-background ratio
Time Frame: day 3
|
day 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with treatment-related adverse events
Time Frame: up to two weeks
|
up to two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: G.M van Dam, prof. dr., UMCG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
June 30, 2015
First Submitted That Met QC Criteria
October 20, 2015
First Posted (Estimate)
October 22, 2015
Study Record Updates
Last Update Posted (Actual)
February 13, 2017
Last Update Submitted That Met QC Criteria
February 10, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL52447.042.15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.