Detection of Lymph Node Metastases in Papillary Thyroid Cancer using EMI-137 enhanced Molecular Fluorescent Guided Imaging: a multicentre feasibility and safety study - Thyroid TARGET study

niversitair Medisch Centrum Groningen0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Age * 18 years, eligible for surgery
•2. Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC 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:
•- 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.

•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 treatment
•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.

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