Fluorescence Guided Surgery in Breast Cancer (MARGIN)

This study has been completed.

Sponsor:

Collaborator:

Martini Hospital Groningen

Information provided by (Responsible Party):

G.M. van Dam, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT02583568

First received: June 30, 2015

Last updated: February 10, 2017

Last verified: February 2017

History of Changes

Purpose

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	Intervention	Phase
Breast Cancer	Drug: Bevacizumab-800CW	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: No masking 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by G.M. van Dam, University Medical Center Groningen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	26
Study Start Date:	October 2015
Study Completion Date:	February 2017
Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02583568

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


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
Study First Received:	June 30, 2015
Last Updated:	February 10, 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

ClinicalTrials.gov processed this record on July 14, 2017

To Top