Status:
COMPLETED
Precision Thyroid Cancer Surgery With Molecular Fluorescent Guided Imaging
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Papillary Thyroid Cancer
Lymph Node Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Almost 50 % of papillary thyroid cancer (PTC) patients have central lymph node metastases (CLNM), which are associated with a high risk of persistent or recurrent disease. However, the practice of per...
Detailed Description
See brief summary
Eligibility Criteria
Inclusion
- Age ≥ 18 years, eligible for surgery
- Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC 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
- 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.
Key Trial Info
Start Date :
June 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03470259
Start Date
June 20 2018
End Date
December 31 2019
Last Update
April 16 2024
Active Locations (2)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
2
Erasmus Medical Center
Rotterdam, Netherlands