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

68Ga-CTR-FAPI PET-CT-guided Precision Surgery for Newly Diagnosed Medullary Thyroid Carcinoma: A Multicenter, Open-labeled, Randomized Controlled Phase 3 Trial

This trial will test whether using 68Ga-CTR-FAPI PET-CT to guide the extent of surgery improves biochemical cure rates for people with newly diagnosed medullary thyroid carcinoma.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07383246 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed, pathologically or cytologically confirmed medullary thyroid carcinoma with elevated calcitonin, resectable locoregional disease without distant metastasis, ECOG 0-1, and scheduled for surgery within 30 days who can consent and adhere to study procedures.

Not a fit: Patients with prior treatment for MTC, distant metastatic disease, poor performance status, or inability to undergo PET-CT or planned surgery are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, CTR-FAPI-guided surgery could increase the chance of biochemical cure and reduce unnecessary neck dissections.

How similar studies have performed: Early diagnostic studies of FAPI tracers have shown improved lesion detection in MTC and other cancers, but randomized evidence that FAPI-guided surgery improves patient outcomes is still novel.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions: Medullary Thyroid Carcinoma, Medullary Thyroid Cariconma, Surgery, CTR-FAPI