NL-OMON51075Not yet recruitingNot Applicable
Detection of thyroid cancer and central lymph node metastases using bevacizumab-IRDye800CW enhanced Molecular Fluorescence Guided Surgery - TARGET-BEVA
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1) Age >= 18 years, eligible for surgery
- •2) Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven
- •PTC/FTC/HTC/PDTC metastasis (primary or recurrence).
- •3) Scheduled to undergo central and/or lateral lymph node dissection with or
- •without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board.
- •4) WHO performance score of 0-2.
- •5) Written informed consent.
- •6) Mentally competent person who is able and willing to comply with study
- •procedures.
- •7) For female subjects who are of childbearing potential are premenopausal with
- •intact reproductive organs or are less than two years post-menopausal:
- •o A negative serum pregnancy test prior to receiving the tracer
- •o Willing to ensure that she or her partner uses effective contraception during
- •the trial and for 3 months thereafter.
Exclusion Criteria
- •1) Pregnancy or breast feeding
- •2) Advanced stage thyroid cancer not suitable for surgical resection
- •3) Medical or psychiatric conditions that compromise the patient*s ability to
- •give informed consent
- •4) Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines,
- •immunotherapy) delivered within the last three months prior to the start of the
- •5) The subject has been included previously in this study or has been injected
- •with another investigational medicinal product within the past six months
- •6) History of myocardial infarction (MI), TIA, CVA, pulmonary embolism,
- •uncontrolled congestive heart failure (CHF), significant liver disease,
- •unstable angina within 6 months prior to enrollment
- •7) Any significant change in their regular prescription or non-prescription
- •medication between 14 days and 1 day prior to IMP administration.
Investigators
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