NCT07423013

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this prospective study, patients with thyroid eye disease, treated with Teprotumumab N01 will be recruited. Clinical efficacy will be evaluated by changes in disease activity, ophthalmic findings, visual function, and quality of life. Advanced imaging techniques, including \[18F\]AlF-NOTA-FAPI-04PET/CT and 5.0-T high-resolution MRI, will be used to assess orbital tissue changes. Safety will be monitored throughout the study by recording adverse events and laboratory findings. The study aims to provide real-world evidence on the effectiveness and safety of Teprotumumab N01 in the management of thyroid eye disease.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-12-31
• Completion: 2027-05-31
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: China