Fluorescence Guided Surgery in Breast Cancer (MARGIN)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Bevacizumab-800CW	Phase 1; Phase 2

Study Design

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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

Arms and Interventions

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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)	Drug: Bevacizumab-800CW; three days prior to surgery bevacizumab-800CW will be administered; Other Name: Bevacizumab-IRDye800CW
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

Outcome Measures

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Primary Outcome Measures :

1. Tumor-to-background ratio [ Time Frame: day 3 ]

Secondary Outcome Measures :

1. Number of participants with treatment-related adverse events [ Time Frame: up to two weeks ]

Eligibility Criteria

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

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ

Sponsors and Collaborators

University Medical Center Groningen

Martini Hospital Groningen

Investigators

Principal Investigator:	G.M van Dam, prof. dr.	UMCG

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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