CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC

Summary

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.

Eligibility

Inclusion Criteria:

* Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:

  1. Pathologically or cytologically confirmed diagnosis;
  2. Elevated serum calcitonin level (\>10 pg/mL);
  3. 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.

Exclusion Criteria:

* History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy).
* Major organ dysfunction, defined as:

  1. Bone marrow impairment: WBC ≤ 4.0×10⁹/L or neutrophils ≤ 1.5×10⁹/L; platelets ≤ 100×10⁹/L; hemoglobin ≤ 90 g/L
  2. 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)
  3. Renal impairment: BUN ≥ 1.5 × ULN; serum creatinine ≥ 1.5 × ULN
* Women who are planning pregnancy, currently pregnant, or breastfeeding.
* History of other malignant tumors;
* Inability to lie flat for at least 30 minutes;
* Known allergy to contrast agents;
* Claustrophobia or other psychiatric disorders that may preclude compliance with study procedures;
* Unwillingness to participate in the clinical trial;
* Assessed as not being a surgical candidate or refusal to undergo surgery;
* Any other condition deemed by the investigator to make the participant unsuitable for the study.

Conditions2

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