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

Last updated: February 18, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

Surgery

Clinical Study ID

NCT06277180
TCR-FAPI for MTC Surgery
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 75 years;
  • Diagnosed with MTC and have surgical indication based on preliminary evaluation; thetumor 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 informedconsent/assent for the trial.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Surgery
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

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

    Beijing, 100021
    China

    Active - Recruiting

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