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Study of Teprotumumab N01 Treatment for Thyroid Eye Disease Using Advanced PETCT and MRI Imaging
Led by Peking University Third Hospital · Updated on 2026-02-20
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Teprotumumab N01 in patients with Thyroid Eye Disease TED. This prospective study uses each patient as their own control by assessing clinical and imaging parameters before and after treatment. The study aims to provide real-world evidence on how Teprotumumab N01 affects disease activity, eye function, and quality of life in TED patients. Participants will receive Teprotumumab N01 treatment and undergo advanced imaging tests, including 18FAlF-NOTA-FAPI-04 PETCT and 5.0-T high-resolution MRI, to monitor changes in orbital tissues. Treatment response will be assessed at 24 and 48 weeks, with safety monitored throughout the study by tracking adverse events and laboratory results. During the study, patients will have clinical evaluations of eye symptoms, visual function, and quality of life. Imaging assessments with PETCT and MRI will occur at specified intervals to measure treatment effects. Researchers will also record laboratory biomarkers and monitor safety and tolerability from the start to week 48. The total study duration includes follow-up assessments up to 48 weeks after treatment begins.
CONDITIONS
Brief Title
Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.
Research Team
Y
Yi Wang
L
Lingge Suo
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