68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking University

Collaborator

Peking University Cancer Hospital & Institute

Collaborator