RecruitingPhase 3NCT07383246

CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC

68Ga-CTR-FAPI PET-CT-guided Precision Surgery for Newly Diagnosed Medullary Thyroid Carcinoma: A Multicenter, Open-labeled, Randomized Controlled Phase 3 Trial

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

150 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Medullary Thyroid Carcinoma

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

Plain Language Summary

Simplified for easier understanding

This study is using a special imaging scan (called CTR-FAPI PET) to help surgeons more precisely map medullary thyroid cancer before surgery. The goal is to improve the accuracy of surgery by identifying exactly where cancer cells are located, including in lymph nodes, that standard scans might miss. **You may be eligible if...** - You have a new (not previously treated) diagnosis of medullary thyroid cancer, confirmed by biopsy or elevated calcitonin blood levels - Your cancer has not spread to distant organs and is removable by surgery - You are in good enough health to undergo surgery within 30 days - You have a life expectancy of at least 12 weeks - You are willing to use effective contraception if of childbearing potential **You may NOT be eligible if...** - You have already had surgery, radiation, or other treatment for medullary thyroid cancer - You have significant problems with bone marrow, liver, or kidney function based on blood tests - You have cancer that has spread to distant parts of the body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURE68Ga-CTR-FAPI PET-CT guided surgery

The participant will be intravenously administered with \[68Ga\]Ga-CTR-FAPI and undergo PET-CT imaging.The surgical extent will be determined by \[68Ga\]Ga-CTR-FAPI PET-CT image. The minimum extent of resection is total thyroidectomy plus central neck dissection. Therapeutic dissection of the lateral neck compartment and upper mediastinal lymph nodes within standard boundaries is performed, with the extent determined based on CTR-FAPI findings.

PROCEDUREinvestigator choice of surgery

Since there is currently no standardized surgical extent for medullary thyroid carcinoma, the surgical approach for the control group will be determined by the attending surgeon. Including but not limited to: Surgery based on conventional imaging (ultrasound/CT); Prophylactic neck dissection; Surgery based on tumor size, germline RET mutation status, and state of central lymph node metastasis; Surgery based on intraoperative frozen section findings.

Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT07383246

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