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RECRUITING
NCT07423013
NA

Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

This is a prospective study designed to evaluate the efficacy and safety of Teprotumumab N01 in patients with Thyroid Eye Disease (TED). Eligible patients will receive Teprotumumab N01 and will be assessed using clinical and imaging parameters before and after treatment, with each patient serving as their own control. The primary endpoint is the overall response rate at Week 24.

Official title: Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease by FAPI PET/CT and 5.0T-MRI

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-11

Completion Date

2027-05-31

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

[18F]AlF-NOTA-FAPI-04PET/CT

\[¹⁸F\]AlF-NOTA-FAPI-04 PET/CT is used as a molecular imaging intervention in Thyroid Eye Disease to noninvasively assess fibroblast activation protein expression in orbital tissues. It enables evaluation of disease activity, orbital involvement, and treatment response by providing quantitative functional imaging beyond conventional anatomical modalities.

DIAGNOSTIC_TEST

5.0-T high-resolution MRI

5.0-T high-resolution MRI is used as an imaging intervention in Thyroid Eye Disease to provide detailed anatomical visualization of the orbit, including extraocular muscles, orbital fat, optic nerve, and soft tissues. It allows precise assessment of disease extent, structural changes, and treatment-related morphological responses.

Locations (1)

Peking University Third Hospital

Beijing, China