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

Trial Details

NCT ID
NCT07383246
Phase
PHASE3
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Status
RECRUITING
Cancer Type
Medullary Thyroid Cancer
Interventions
  • 68Ga-CTR-FAPI PET-CT guided surgery
  • investigator choice of surgery
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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