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CompletedNCT02583568MARGINUpdated Feb 13, 2017

Fluorescence Guided Surgery in Breast Cancer

A Phase 1/2 interventional study of Bevacizumab-800CW in Breast Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-13.

Sponsored by University Medical Center Groningen · Phase 1/2, Interventional, and Diagnostic

Phase
Phase 1/2
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • image-guided surgery
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 26 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugBevacizumab-800CW

    three days prior to surgery bevacizumab-800CW will be administered

    Also known as: Bevacizumab-IRDye800CW

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What researchers measure

Primary outcomes

  1. Tumor-to-background ratio

    Time frame: day 3

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: up to two weeks

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02583568
Lead sponsor
University Medical Center Groningen
Collaborators
Martini Hospital Groningen
Responsible party
G.M. van Dam (prof.dr., University Medical Center Groningen) — Principal investigator
First posted
Oct 22, 2015
Start date
Oct 2015
Primary completion
Jan 2017
Completion
Feb 2017
Last update
Feb 13, 2017

Study contacts

G.M van Dam, prof. dr.
principal investigator · UMCG

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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