68Ga-CTR-FAPI PET-CT-guided Precision Surgery for Newly Diagnosed Medullary Thyroid Carcinoma: A Multicenter, Open-labeled, Randomized Controlled Phase 3 Trial
This is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial, aims to compare 68Ga-CTR-FAPI PET-CT-guided surgery to investigator-chosen surgical approaches to evaluate its efficacy in treating newly diagnosed medullary thyroid carcinoma. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice). The primary endpoint is the biochemical cure rate, with secondary endpoints including the biochemical cure rate in the R0 resection subgroup, the unnecessary dissection rate in the biochemical-cured subgroup, 3-year recurrence-free survival, the rate of change in surgical extent, and diagnostic accuracy.
• Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
‣ Pathologically or cytologically confirmed diagnosis;
⁃ Elevated serum calcitonin level (\>10 pg/mL);
⁃ Other infectious or neoplastic diseases excluded.
• Life expectancy ≥ 12 weeks;
• ECOG performance status of 0 or 1;
• Absence of distant metastasis confirmed by conventional imaging, with resectable locoregional disease;
• Scheduled to undergo surgery within 30 days;
• Females of childbearing potential must use effective contraception (e.g., sterilization, intrauterine device, condoms, oral/injectable contraceptives, abstinence, or partner vasectomy) during the study and for 6 months after study completion. Male participants must agree to use effective contraception during the same period;
• Capable of understanding and voluntarily signing the informed consent form with good compliance.