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.
Pathologically or cytologically confirmed diagnosis;
Elevated serum calcitonin level (>10 pg/mL);
Other infectious or neoplastic diseases excluded.
Life expectancy ≥ 12 weeks;
History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy).
Bone marrow impairment: WBC ≤ 4.0×10⁹/L or neutrophils ≤ 1.5×10⁹/L; platelets ≤ 100×10⁹/L; hemoglobin ≤ 90 g/L
Hepatic impairment: PT or APTT ≥ 1.5 × ULN; total bilirubin ≥ 1.5 × ULN; ALT/AST ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with liver metastases); ALP ≥ 2.5 × ULN (or ≥ 4.5 × ULN in cases with bone or liver metastases)
Renal impairment: BUN ≥ 1.5 × ULN; serum creatinine ≥ 1.5 × ULN
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Peking Union Medical College Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Peking University First Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Collaborator