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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Surgery
- Surgery
Treatment groups
Sponsors and collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Peking University
Collaborator
Peking University Cancer Hospital & Institute
Collaborator