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

50 Participants
are divided into 3 treatment groups

Locations

1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College100021, Beijing China

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking University

Collaborator

Peking University Cancer Hospital & Institute

Collaborator