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)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
50 participants
Oct 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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.
Interventions
Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all 68Ga-TCR-FAPI-avid lesions are resected.
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)
View Full Details on ClinicalTrials.gov
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NCT06277180