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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06359795
Enrollment
50
Registered
2024-04-11
Start date
2023-12-15
Completion date
2027-12-31
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease

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.

Detailed description

Subjects with TED underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT for activity assessment within a 10-day period. On 18F-AlF-FAPI PET/CT, uptake in the extraocular muscles was quantified using SUV metrics and target-to-background ratio. On 99mTc-DTPA SPECT/CT, uptake in the extraocular muscles was semi-quantified using the uptake ratio. Activity of TED was determined through comprehensive clinical data. The correlation between SUV metrics and activity status was calculated to explore the value of 18F-AlF-FAPI PET/CT in assessing TED activity. The diagnostic accuracy of 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT in assessing TED activity was compared. Additionally, the correlation of changes in SUV metrics and therapy response will be calculated to explore the value of 18F-AlF-FAPI PET/CT in therapy response assessment of TED.

Interventions

DIAGNOSTIC_TEST18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracythrough study completion, an average of 6 monthsThe accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.

Secondary

MeasureTime frameDescription
The value to predict therapy responsethrough study completion, an average of 12 monthsThe changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response
Diagnostic accuracy comparisonthrough study completion, an average of 6 monthsComparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.
FAPI expression and SUV metricsthrough study completion, an average of 12 monthsCorrelation between SUV metrics on PET and FAPI expression in patients with surgery.

Countries

China

Contacts

Primary ContactHui Li, Dr.
huilee1990@163.com86-13121136769
Backup ContactLingge Suo, Dr.
suolingge_1019@126.com86-010-82264935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026