Actively Recruiting
CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-02-03
150
Participants Needed
1
Research Sites
331 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial, aims to compare 68Ga-CTR-FAPI PET-CT-guided surgery to investigator-chosen surgical approaches to evaluate its efficacy in treating newly diagnosed medullary thyroid carcinoma. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice). The primary endpoint is the biochemical cure rate, with secondary endpoints including the biochemical cure rate in the R0 resection subgroup, the unnecessary dissection rate in the biochemical-cured subgroup, 3-year recurrence-free survival, the rate of change in surgical extent, and diagnostic accuracy.
CONDITIONS
Official Title
CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed medullary thyroid carcinoma confirmed by pathology or cytology
- Elevated serum calcitonin level greater than 10 pg/mL
- No other infectious or cancerous diseases
- Life expectancy of at least 12 weeks
- ECOG performance status 0 or 1
- No distant metastasis confirmed by imaging and disease is resectable locally
- Scheduled for surgery within 30 days
- Females of childbearing potential agree to use effective contraception during the study and for 6 months after
- Male participants agree to use effective contraception during the same period
- Able to understand and voluntarily sign informed consent with good compliance
You will not qualify if you...
- Previous treatment for medullary thyroid carcinoma such as surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy
- Major organ dysfunction including low white blood cell or platelet counts, low hemoglobin, abnormal liver function tests, or impaired kidney function
- Women who are pregnant, planning pregnancy, or breastfeeding
- History of other cancers
- Inability to lie flat for at least 30 minutes
- Known allergy to contrast agents
- Claustrophobia or psychiatric disorders interfering with study compliance
- Unwillingness to participate in the clinical trial
- Not a surgical candidate or refusal to undergo surgery
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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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, Beijing Municipality, China, 10005
Actively Recruiting
Research Team
Z
Ziren Kong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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