Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW
- Conditions
- Thyroid CarcinomaSurgery
- Registration Number
- NCT06095362
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion criteria<br><br> 1. Age = 18 years, eligible for surgery<br><br> 2. Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC<br> metastasis (primary or recurrence).<br><br> 3. Scheduled to undergo central and/or lateral lymph node dissection with or without<br> thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board.<br><br> 4. WHO performance score of 0-2.<br><br> 5. Written informed consent.<br><br> 6. Mentally competent person who is able and willing to comply with study procedures.<br><br> 7. For female subjects who are of childbearing potential are premenopausal with intact<br> reproductive organs or are less than two years post-menopausal:<br><br> - A negative serum pregnancy test prior to receiving the tracer<br><br> - Willing to ensure that she or her partner uses effective contraception during<br> the trial and for 3 months thereafter.<br><br>Exclusion criteria<br><br> 1. Pregnancy or breast feeding<br><br> 2. Advanced stage thyroid cancer not suitable for surgical resection<br><br> 3. Medical or psychiatric conditions that compromise the patient's ability to give<br> informed consent<br><br> 4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy)<br> delivered within the last three months prior to the start of the treatment<br><br> 5. The subject has been included previously in this study or has been injected with<br> another investigational medicinal product within the past six months<br><br> 6. History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled<br> congestive heart failure (CHF), significant liver disease, unstable angina within 6<br> months prior to enrollment<br><br> 7. Any significant change in their regular prescription or non-prescription medication<br> between 14 days and 1 day prior to IMP administration.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fluorescent signal levels defined as Tumor-to-Background Ratio (TBR) derived from PTC/FTC/HTC nodal metastasis and normal tissue to determine the optimal dose of Bevacizumab-800CW in patients with PTC/FTC/HTC
- Secondary Outcome Measures
Name Time Method Correlation of the fluorescent signal assessed by MFGS with other biological and molecular parameters (IHC) and the fluorescent signal assessed in the ex vivo biopsy specimens.;Wound bed biopsy specimen characteristics (number of positive and negative biopsies.;Distribution of bevacizumab-IRDye800CW in PTC/FTC/HTC, lymph nodes and normal tissue as identified by SDS-PAGE and/or ELISA and/or fluorescence microscopy.;Quantification of sensitivity and specificity of Bevacizumab-800CW in order to make a power size calculation for a possible subsequent diagnostic accuracy study.