Fluorescence Guided Surgery in Breast Cancer (MARGIN)
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ClinicalTrials.gov Identifier: NCT02583568 |
Recruitment Status
:
Completed
First Posted
: October 22, 2015
Last Update Posted
: February 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Bevacizumab-800CW | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 Start Date : | October 2015 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | February 2017 |

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)
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Drug: Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Other Name: Bevacizumab-IRDye800CW
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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.
|
Drug: Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Other Name: Bevacizumab-IRDye800CW
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- Tumor-to-background ratio [ Time Frame: day 3 ]
- Number of participants with treatment-related adverse events [ Time Frame: up to two weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583568
Netherlands | |
University Medical Center Groningen | |
Groningen, Netherlands, 9713 GZ |
Principal Investigator: | G.M van Dam, prof. dr. | UMCG |
Responsible Party: | G.M. van Dam, prof.dr., University Medical Center Groningen |
ClinicalTrials.gov Identifier: | NCT02583568 History of Changes |
Other Study ID Numbers: |
NL52447.042.15 |
First Posted: | October 22, 2015 Key Record Dates |
Last Update Posted: | February 13, 2017 |
Last Verified: | February 2017 |
Keywords provided by G.M. van Dam, University Medical Center Groningen:
breast cancer image-guided surgery |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |