CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
Recruiting
Phase 3
Interventional Study
Medullary Thyroid Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Other
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About This Trial
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 (s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
1. Pathologically or cytologically confirmed diagnosis;
2. Elevated serum calcitonin level (\>10 pg/mL);
3. Other infectious or neoplastic diseases excluded.
* Life expectancy ≥ 12…
Contacts