NCT07383246RecruitingPhase 3
CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
68Ga-CTR-FAPI PET-CT-guided Precision Surgery for Newly Diagnosed Medullary Thyroid Carcinoma: A Multicenter, Open-labeled, Randomized Controlled Phase 3 Trial
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 25 Aug 2025
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Thyroid cancer, Childhood cancers
- NCT number
- NCT07383246
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 25 Aug 2025 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy).
- Assessed as not being a surgical candidate or refusal to undergo surgery;
Other illness
- History of other malignant tumors;
- Known allergy to contrast agents;
- Claustrophobia or other psychiatric disorders that may preclude compliance with study procedures;
- Any other condition deemed by the investigator to make the participant unsuitable for the study.
Lab values
- Major organ dysfunction, defined as:
- 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
Other
- Women who are planning pregnancy, currently pregnant, or breastfeeding.
- Inability to lie flat for at least 30 minutes;
- Unwillingness to participate in the clinical trial;
Who the study is looking for
- Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
- Pathologically or cytologically confirmed diagnosis;
- Elevated serum calcitonin level (\>10 pg/mL);
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.