68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT to Guide the Surgical Treatment for Medullary Thyroid Carcinoma (MTC)

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Medullary Thyroid Cancer; Fibroblast Activation Protein Inhibitor; Prositron Emission Tomography
• Intervention / Treatment: Procedure: Surgery; Procedure: Surgery

Detailed Description

Surgery remains the only curative option for MTC, yet the current imaging-based method (ultrasound, CT, MRI, 18F-FDG PET/CT) or calcitonin-based method are insufficient to map the extent of disease. In the previous studies, TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention, and better diagnosed MTC than the current radiotracers.

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and the principles of surgery remains the same with differentiated thyroid carcinoma (i.e., lymph node dissection of level II-IV is required if lateral neck lymph node is considered metastasis). The primary endpoint of the study is 1-month post-surgical calcitonin level, and the secondary endpoints include the 2-year event free survival (EFS), the ratio of patient that change surgical plan, and the accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions.

Patient will be divided into three arms: 1) newly diagnosed MTC and all 68Ga-TCR-FAPI PET/CT avid lesions are resected; 2) recurrent/persistent MTC and all 68Ga-TCR-FAPI PET/CT avid lesions are resected; 3) distant metastasis or unresectable lesions shown by 68Ga-TCR-FAPI PET/CT imaging but still recommended for surgical treatment. The three arms will not be compared between each other but will be separately analyzed.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaoyan Liu, M.D.; Phone Number: 0086-010-87787190; Email: shaoyanliu.bj@263.net

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Shaoyan Liu, M.D.; Phone Number: 0086-010-87787190; Email: shaoyanliu.bj@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 75 years；
• Diagnosed with MTC and have surgical indication based on preliminary evaluation; the tumor may be newly diagnosed or previously treated;
• Expected survival of at least 12 weeks;
• No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
• Be willing and able to understand the research content and provide written informed consent/assent for the trial.

Exclusion Criteria:

• Have a history of imaging agent allergies;
• Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination;
• Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
• No surgical indication (i.e., no measurable disease, unresectable disease, or significant present of distant metastasis), refusing surgery or 68Ga-TCR-FAPI PET/CT-guided surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newly diagnosed MTC that resect all 68Ga-TCR-FAPI-avid lesions; Newly diagnosed MTC (did not receive previous surgery, radiotherapy or target therapy) and all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be successfully resected.	Procedure: Surgery; Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all 68Ga-TCR-FAPI-avid lesions are resected.; Procedure: Surgery; 68Ga-TCR-FAPI PET/CT identified distant metastasis or unresectable lesions, but the patient is still recommended to undergo surgery for debulking or reduce symptoms.
Experimental: Recurrent/persistent MTC that resect all 68Ga-TCR-FAPI-avid lesions; Recurrent/persistent MTC (underwent previous surgery with currently biochemical recurrent/residual disease) and all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be successfully resected.	Procedure: Surgery; Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all 68Ga-TCR-FAPI-avid lesions are resected.; Procedure: Surgery; 68Ga-TCR-FAPI PET/CT identified distant metastasis or unresectable lesions, but the patient is still recommended to undergo surgery for debulking or reduce symptoms.
Experimental: Not all 68Ga-TCR-FAPI-avid lesions can be resected; Not all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be resected.	Procedure: Surgery; Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all 68Ga-TCR-FAPI-avid lesions are resected.; Procedure: Surgery; 68Ga-TCR-FAPI PET/CT identified distant metastasis or unresectable lesions, but the patient is still recommended to undergo surgery for debulking or reduce symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-month post-surgery calcitonin level	1-month post-surgery calcitonin level	1-month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year event free survival	2-year event free survival	2-year post-surgery
Ratio of patient that change surgical plan	Ratio of patient that change surgical plan	immediately after surgery
Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions	Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions	1-month post-surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Peking University; Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Medullary Thyroid Cancer; Fibroblast Activation Protein Inhibitor; Prositron Emission Tomography
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: TCR-FAPI for MTC Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No