Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT to Guide the Surgical Treatment for Medullary Thyroid Carcinoma (MTC)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
Shaoyan Liu, M.D.
shaoyanliu.bj@263.net
0086-010-87787190
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Newly diagnosed MTC that resect all 68Ga-TCR-FAPI-avid lesions
Newly diagnosed MTC (did not receive previous surgery, radiotherapy or target therapy) and all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be successfully resected.
Experimental: Recurrent/persistent MTC that resect all 68Ga-TCR-FAPI-avid lesions
Recurrent/persistent MTC (underwent previous surgery with currently biochemical recurrent/residual disease) and all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be successfully resected.
Experimental: Not all 68Ga-TCR-FAPI-avid lesions can be resected
Not all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be resected.
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators: Peking University Cancer Hospital & Institute, Peking University

This content was sourced from clinicaltrials.gov