Back to resultsFluorescence Guided Surgery in Breast Cancer (MARGIN)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bevacizumab-800CW
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, image-guided surgery
Eligibility Criteria
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.
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1
Part 2
Arm Description
In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
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.
Outcomes
Primary Outcome Measures
Tumor-to-background ratio
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Full Information
NCT ID
NCT02583568
First Posted
June 30, 2015
Last Updated
February 10, 2017
Sponsor
University Medical Center Groningen
Collaborators
Martini Hospital Groningen
1. Study Identification
Unique Protocol Identification Number
NCT02583568
Brief Title
Fluorescence Guided Surgery in Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Martini Hospital Groningen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, image-guided surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Description
In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
Arm Title
Part 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab-800CW
Other Intervention Name(s)
Bevacizumab-IRDye800CW
Intervention Description
three days prior to surgery bevacizumab-800CW will be administered
Primary Outcome Measure Information:
Title
Tumor-to-background ratio
Time Frame
day 3
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
up to two weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G.M van Dam, prof. dr.
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Fluorescence Guided Surgery in Breast Cancer
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