Neoplasms

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Gland and Hormone Related Diseases

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Thyroid Neoplasms

Thyroid Diseases

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Thyroid Cancer, Medullary

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.

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.

Not all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be resected.

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.

Shaoyan Liu, M.D.

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.

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.

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)

Ratio of patient that change surgical plan

Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC	NCT06277180	Medullary Thyro... Prositron Emiss... Fibroblast Acti... Surgery	Surgery Surgery	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC	NCT06277180	Medullary Thyro... Prositron Emiss... Fibroblast Acti... Surgery	Surgery Surgery	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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