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NCT Number: NCT06359795

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic accuracy

    Time frame: through study completion, an average of 6 months

    The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.

Secondary outcomes

  1. The value to predict therapy response

    Time frame: through study completion, an average of 12 months

    The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response

  2. Diagnostic accuracy comparison

    Time frame: through study completion, an average of 6 months

    Comparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.

  3. FAPI expression and SUV metrics

    Time frame: through study completion, an average of 12 months

    Correlation between SUV metrics on PET and FAPI expression in patients with surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Li, Dr.

CONTACT

[email protected]

86-13121136769

Lingge Suo, Dr.

CONTACT

[email protected]

86-010-82264935

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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