Thyroid Eye Disease Clinical Trial
Official title:
Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease
FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age = 18 years; 2. Patients diagnosed with TED; 3. Complete understanding and voluntary participation in this study, with the signing of an informed consent form. Exclusion Criteria: 1. Severe liver or kidney dysfunction; 2. Inability to maintain a supine position for 5 minutes to cooperate with the examination; 3. Suffering from claustrophobia or other psychiatric disorders; 4. Patients planning pregnancy or in the prenatal or lactation period; 5. Other conditions deemed unsuitable for participation in the trial by the investigator. |
Country | Name | City | State |
---|---|---|---|
China | Dept. of Nuclear Medicine, Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy | The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED. | through study completion, an average of 6 months | |
Secondary | The value to predict therapy response | The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response | through study completion, an average of 12 months | |
Secondary | Diagnostic accuracy comparison | Comparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT. | through study completion, an average of 6 months | |
Secondary | FAPI expression and SUV metrics | Correlation between SUV metrics on PET and FAPI expression in patients with surgery. | through study completion, an average of 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04583735 -
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
|
Phase 4 | |
Active, not recruiting |
NCT05002998 -
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
|
Phase 4 | |
Withdrawn |
NCT02422368 -
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
|
Phase 2/Phase 3 | |
Completed |
NCT03298867 -
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
|
Phase 3 | |
Recruiting |
NCT05987423 -
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
|
Phase 3 | |
Recruiting |
NCT06112340 -
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
|
Phase 2/Phase 3 | |
Recruiting |
NCT05517447 -
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
|
Phase 3 | |
Terminated |
NCT04737330 -
A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)
|
Phase 3 | |
Recruiting |
NCT05517421 -
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
|
Phase 3 | |
Recruiting |
NCT04311606 -
Anti-VEGF Therapy for Acute Thyroid Eye Disease
|
Phase 2 | |
Recruiting |
NCT06106828 -
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2)
|
Phase 3 | |
Recruiting |
NCT06021054 -
A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
|
Phase 3 | |
Not yet recruiting |
NCT06413043 -
Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy
|
N/A | |
Not yet recruiting |
NCT06401044 -
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
|
Phase 1 | |
Recruiting |
NCT06384547 -
A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
|
Phase 3 | |
Recruiting |
NCT06367517 -
Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)
|
||
Recruiting |
NCT06275373 -
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
|
||
Enrolling by invitation |
NCT05241626 -
AS-OCT of the Cornea in Thyroid Diseases
|
||
Active, not recruiting |
NCT05776121 -
Study of ZB001 in Chinese Patients With Thyroid Eye Disease
|
Phase 1 | |
Recruiting |
NCT04359979 -
Tamsulosin for Thyroid Lid Retraction
|
N/A |