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RECRUITINGINTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form/assent for the trial. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

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