OncoMatch/Clinical Trials/NCT07383246
CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
Is NCT07383246 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for medullary thyroid carcinoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Thyroid Cancer
Disease stage
Excluded: Stage DISTANT METASTASIS
Absence of distant metastasis confirmed by conventional imaging, with resectable locoregional disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy)
Cannot have received: radiotherapy
History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy)
Cannot have received: targeted therapy
History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy)
Cannot have received: radionuclide therapy
History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy)
Cannot have received: interventional therapy
History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy)
Lab requirements
Blood counts
wbc ≤ 4.0×10⁹/l or neutrophils ≤ 1.5×10⁹/l; platelets ≤ 100×10⁹/l; hemoglobin ≤ 90 g/l
Kidney function
bun ≥ 1.5 × uln; serum creatinine ≥ 1.5 × uln
Liver function
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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