CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC

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.

Conditions

• Medullary Thyroid Carcinoma

Interventions

PROCEDURE

68Ga-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.

PROCEDURE

investigator 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Shaoyan Liu, MD · Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-25

Primary Completion

2028-09-01

Completion

2031-12-31

Countries

• China

Study Locations