NCT07383246 CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
| NCT ID | NCT07383246 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Medullary Thyroid Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2025-08-25 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Shaoyan Liu, MD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT07383246 clinical trial?
This trial is open to participants of all sexes, studying Medullary Thyroid Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07383246 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT07383246 currently recruiting?
Yes, NCT07383246 is actively recruiting participants. Contact the research team at kongziren@pumc.edu.cn for enrollment information.
Where is the NCT07383246 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07383246 clinical trial?
NCT07383246 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Shaoyan Liu, MD at Chinese Academy of Medical Sciences. The trial plans to enroll 150 participants.