CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC

NCT07383246 | Recruiting Phase 3 DMC

• 1 other identifier: CAST-MTC-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Medullary Thyroid Cariconma; Surgery; CTR-FAPI

Outcome Measures

Primary Outcomes (1)

• Biochemical cure rate

  Biochemical cure is defined as postoperative serum calcitonin level less than 10pg/ml

  1 month after surgery

Secondary Outcomes (5)

• Biochemical cure rate in R0 resection subgroup

  1 month after surgery

• Unnecessary dissection rate in the biochemical cured subgroup

  1month after surgery (after pathogoly report issued)

• Recurrence-free survival

  3 years after surgery

• Change rate in the extent of surgery in the experimental arm

  immedaite after surgery

• Diagnostic accuracy rate

  1 month after surgery (after pathology report issued)

Study Arms (2)

⁶⁸Ga-CTR-FAPI PET-CT guided surgery

EXPERIMENTAL

The participants assigned to the experimental arm will undergo ⁶⁸Ga-CTR-FAPI PET-CT imaging. The surgical extent will be determined by ⁶⁸Ga-CTR-FAPI PET-CT image.

Procedure: 68Ga-CTR-FAPI PET-CT guided surgery

investigator choice of surgery

ACTIVE COMPARATOR

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, based on routine preoperative evaluation.

Procedure: investigator choice of surgery

Interventions

68Ga-CTR-FAPI PET-CT guided surgery PROCEDURE

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.

⁶⁸Ga-CTR-FAPI PET-CT guided surgery

investigator choice of surgery PROCEDURE

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.

investigator choice of surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Life expectancy ≥ 12 weeks;
• ECOG performance status of 0 or 1;
• Absence of distant metastasis confirmed by conventional imaging, with resectable locoregional disease;
• Scheduled to undergo surgery within 30 days;
• Females of childbearing potential must use effective contraception (e.g., sterilization, intrauterine device, condoms, oral/injectable contraceptives, abstinence, or partner vasectomy) during the study and for 6 months after study completion. Male participants must agree to use effective contraception during the same period;
• Capable of understanding and voluntarily signing the informed consent form with good compliance.

You may not qualify if:

• History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy).
• Major organ dysfunction, defined as:
• Bone marrow impairment: WBC ≤ 4.0×10⁹/L or neutrophils ≤ 1.5×10⁹/L; platelets ≤ 100×10⁹/L; hemoglobin ≤ 90 g/L
• Hepatic impairment: 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)
• Renal impairment: BUN ≥ 1.5 × ULN; serum creatinine ≥ 1.5 × ULN
• Women who are planning pregnancy, currently pregnant, or breastfeeding.
• History of other malignant tumors;
• Inability to lie flat for at least 30 minutes;
• Known allergy to contrast agents;
• Claustrophobia or other psychiatric disorders that may preclude compliance with study procedures;
• Unwillingness to participate in the clinical trial;
• Assessed as not being a surgical candidate or refusal to undergo surgery;
• Any other condition deemed by the investigator to make the participant unsuitable for the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Peking Union Medical College Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Peking University First Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator

Study Sites (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, 10005, China

RECRUITING

Related Publications (2)

• Kong Z, Li Z, Cui XY, Wang J, Xu M, Liu Y, Chen J, Ni S, Zhang Z, Fan X, Huang J, Lin Y, Sun Y, He Y, Lin X, Meng T, Li H, Song Y, Peng B, An C, Gao C, Li N, Liu C, Zhu Y, Yang Z, Liu Z, Liu S. CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma. Cancer Discov. 2025 Feb 7;15(2):316-328. doi: 10.1158/2159-8290.CD-24-0897.

  PMID: 39470165 RESULT

• Cui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22.

  PMID: 38778111 RESULT

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Shaoyan Liu, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziren Kong, MD

CONTACT

0086-18500487274; kongziren@pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Head and Neck Surgery

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: August 25, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)