Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW (TARGET-beva)
Thyroid Carcinoma, Surgery
About this trial
This is an interventional diagnostic trial for Thyroid Carcinoma focused on measuring Optical Molecular Imaging, Molecular Fluorescence Guided Surgery
Eligibility Criteria
Inclusion criteria Age ≥ 18 years, eligible for surgery Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC metastasis (primary or recurrence). Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board. WHO performance score of 0-2. Written informed consent. Mentally competent person who is able and willing to comply with study procedures. For female subjects who are of childbearing potential are premenopausal with intact reproductive organs or are less than two years post-menopausal: A negative serum pregnancy test prior to receiving the tracer Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Exclusion criteria Pregnancy or breast feeding Advanced stage thyroid cancer not suitable for surgical resection Medical or psychiatric conditions that compromise the patient's ability to give informed consent Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months 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 Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Experimental
Intervention group