Status:
RECRUITING
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University
Peking University Cancer Hospital & Institute
Conditions:
Medullary Thyroid Cancer
Prositron Emission Tomography
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 tre...
Detailed Description
Surgery remains the only curative option for MTC, yet the current imaging-based method (ultrasound, CT, MRI, 18F-FDG PET/CT) or calcitonin-based method are insufficient to map the extent of disease. I...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06277180
Start Date
October 1 2023
End Date
December 31 2027
Last Update
February 26 2024
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021