CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC

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.

NCT Number	NCT07383246
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences Collaborators: Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Peking University First Hospital, Xiangya Hospital of Central South University, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Conditions	Medullary Thyroid Carcinoma
Enrollment	150 participants
Start Date	2025-08-25
Primary Completion	2028-09-01 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-03