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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277180
• Other study ID #: TCR-FAPI for MTC Surgery
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Shaoyan Liu, M.D.
• Phone: 0086-010-87787190
• Email: shaoyanliu.bj[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medullary Thyroid Cancer
• Surgery
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Peking University, Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-month post-surgery calcitonin level	1-month post-surgery calcitonin level	1-month post-surgery
Secondary	2-year event free survival	2-year event free survival	2-year post-surgery
Secondary	Ratio of patient that change surgical plan	Ratio of patient that change surgical plan	immediately after surgery
Secondary	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