Actively Recruiting
Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT to Guide Surgical Treatment for Medullary Thyroid Carcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-02-26
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
P
Peking University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a specialized imaging technique called 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide surgery for medullary thyroid carcinoma (MTC). Surgery is currently the only curative option for MTC, but existing imaging methods and calcitonin tests are not sufficient to fully map the disease. This study focuses on whether 68Ga-TCR-FAPI PET/CT can better identify the extent of MTC and improve surgical planning. Participants are divided into three groups: those newly diagnosed with MTC, those with recurrent or persistent MTC after prior treatment, and those with distant or unresectable lesions but still recommended for surgery. Surgery will be performed based on the lesion range revealed by the 68Ga-TCR-FAPI PET/CT scan, aiming to remove all identified lesions when possible. The surgical principles follow current standards, including lymph node dissection when needed. During the study, researchers will measure calcitonin levels one month after surgery as the primary outcome. Secondary outcomes include two-year event-free survival, how often surgical plans change based on imaging results, and the accuracy of 68Ga-TCR-FAPI PET/CT in detecting MTC lesions. Participants will undergo PET/CT scans, surgery guided by imaging findings, and follow-up assessments to monitor outcomes and safety up to two years after surgery.
CONDITIONS
Brief Title
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with medullary thyroid carcinoma and have a surgical recommendation
- Newly diagnosed or previously treated tumor with surgical indication
- Expected survival of at least 12 weeks
- No major organ dysfunction including heart, lung, liver, kidney
- Able and willing to understand the study and provide written consent
You will not qualify if you...
- History of allergies to imaging agents
- Do not meet sedation requirements or have contraindications for PET-CT
- Pregnant, breastfeeding, or planning to conceive during the study
- No surgical indication or refusing surgery or PET/CT-guided surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical period plus immediate post-operative care
Participants undergo surgery guided by 68Ga-TCR-FAPI PET/CT imaging to remove medullary thyroid carcinoma lesions based on the lesion range identified. Surgery may involve resecting all PET/CT-avid lesions or debulking unresectable lesions to reduce symptoms.
1 surgical visit followed by post-operative care visits as needed
Duration - Up to 2 years post-surgery
Participants are monitored after surgery to assess outcomes including calcitonin levels and event-free survival, and to evaluate the effectiveness of PET/CT guided surgical planning.
Follow-up visits at 1 month and periodically up to 2 years post-surgery
Trial Site Locations
Total: 1 location
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
Actively Recruiting
Research Team
S
Shaoyan Liu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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