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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
June 30, 2015
February 10, 2017
October 2015
January 2017   (Final data collection date for primary outcome measure)
Tumor-to-background ratio [ Time Frame: day 3 ]
Same as current
Complete list of historical versions of study NCT02583568 on ClinicalTrials.gov Archive Site
Number of participants with treatment-related adverse events [ Time Frame: up to two weeks ]
Same as current
Not Provided
Not Provided
 
Fluorescence Guided Surgery in Breast Cancer
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Diagnostic
Breast Cancer
Drug: Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Other Name: Bevacizumab-IRDye800CW
  • 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)
    Intervention: Drug: Bevacizumab-800CW
  • 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.
    Intervention: Drug: Bevacizumab-800CW
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 2017
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT02583568
NL52447.042.15
Yes
Not Provided
Not Provided
G.M. van Dam, University Medical Center Groningen
University Medical Center Groningen
Martini Hospital Groningen
Principal Investigator: G.M van Dam, prof. dr. UMCG
University Medical Center Groningen
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP