Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

NCT06359795 | Recruiting

• 1 other identifier: FAPI-TED
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The value to predict therapy response

  through study completion, an average of 12 months

• Diagnostic accuracy comparison

  through study completion, an average of 6 months

• FAPI expression and SUV metrics

  through study completion, an average of 12 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients with TED will be recruited in the study. Interventions: Diagnostic Test: 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.

Diagnostic Test: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT

Interventions

18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT DIAGNOSTIC_TEST

Patients underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT scans within 10 days.

Experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients diagnosed with TED;
• Complete understanding and voluntary participation in this study, with the signing of an informed consent form.

You may not qualify if:

• Severe liver or kidney dysfunction;
• Inability to maintain a supine position for 5 minutes to cooperate with the examination;
• Suffering from claustrophobia or other psychiatric disorders;
• Patients planning pregnancy or in the prenatal or lactation period;
• Other conditions deemed unsuitable for participation in the trial by the investigator.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dept. of Nuclear Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hui Li, Dr.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Li, Dr.

CONTACT

86-13121136769; huilee1990@163.com

Lingge Suo, Dr.

CONTACT

86-010-82264935; suolingge_1019@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: December 15, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)