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
Parallel
68Ga-CTR-FAPI PET-CT guided surgery
Procedure/SurgeryThe participant will be intravenously administered with \[68Ga\]Ga-CTR-FAPI and undergo PET-CT imaging.The surgical extent will be determined by \[68Ga\]Ga-CTR-FAPI PET-CT image. The minimum extent of resection is total thyroidectomy plus central neck dissection. Therapeutic dissection of the lateral neck compartment and upper mediastinal lymph nodes within standard boundaries is performed, with the extent determined based on CTR-FAPI findings.
investigator choice of surgery
Procedure/SurgerySince there is currently no standardized surgical extent for medullary thyroid carcinoma, the surgical approach for the control group will be determined by the attending surgeon. Including but not limited to: Surgery based on conventional imaging (ultrasound/CT); Prophylactic neck dissection; Surgery based on tumor size, germline RET mutation status, and state of central lymph node metastasis; Surgery based on intraoperative frozen section findings.
Biochemical cure rate
Biochemical cure is defined as postoperative serum calcitonin level less than 10pg/ml
Biochemical cure rate in R0 resection subgroup
Biochemical cure is defined as postoperative serum calcitonin level less than 10pg/ml. The outcome is assessed in the R0 resecton subgroup.
Unnecessary dissection rate in the biochemical cured subgroup
The unnecessary dissection rate is defined as the proportion of patients whose dissections outside the central compartment yield no metastatic lymph nodes. This outcome will be evaluated exclusively in the biochemically cured subgroup, as only surgeries that achieve biochemical cure are considered to have an adequate surgical extent. In these patients, any dissection that yields negative specimens is deemed unnecessary. We anticipate that CTR-FAPI imaging will enable precise surgical planning, allowing for a more reduced extent of dissection compared to prophylactic surgery, thus minimizing complications.
Recurrence-free survival
Recurrence-free survival is defined as the peroid from the date of surgery until any recurrence revealed by structural imaging or any cause of death. The day of imaging examination will be regarded as the day of recurrence.
Change rate in the extent of surgery in the experimental arm
Change rate in the extent of surgery compared to the investigator's chioce in the experimental arm. The investigator's chosen surgical extent will be documented preoperatively when the attending doctor is not exposed to the CTR-FAPI findings.
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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
