Precision surgery guided by 68Ga-CTR-FAPI for newly diagnosed medullary thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label Phase 3 trial will enroll 150 newly diagnosed MTC patients and randomize them 2:1 to surgery guided by 68Ga-CTR-FAPI PET-CT versus surgeon-selected standard surgery. The experimental arm uses molecular imaging that targets fibroblast activation protein (FAP) to map tumor-associated stromal sites that co-localize with MTC, while the control arm follows the investigator's usual surgical plan. The primary endpoint is biochemical cure rate, with secondary endpoints including R0 subgroup cure rate, unnecessary dissection rate among biochemically cured patients, 3-year recurrence-free survival, changes in surgical extent, and diagnostic accuracy. The trial aims to determine if CTR-FAPI guidance can better identify disease extent to optimize resection while avoiding overtreatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Shaoyan Liu, MD — Chinese Academy of Medical Sciences
• Study coordinator: Ziren Kong, MD
• Email: kongziren@pumc.edu.cn
• Phone: 0086-18500487274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.