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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.

Phase 3RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT07383246Data as of May 2026

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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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