68ga-tcr-fapi pet/ct guided precision surgery for mtc

Conditions: Medullary Thyroid Cancer; Prositron Emission Tomography; Fibroblast Activation Protein Inhibitor; Surgery

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.

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.

Eligibility criteria:
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.

Keywords: medullary thyroid cancer prositron emission tomography fibroblast activation protein inhibitor surgery