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临床试验/NCT06359795
NCT06359795
招募中
不适用

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

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 50 人2023年12月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Thyroid Eye Disease
发起方
Peking University Third Hospital
入组人数
50
试验地点
1
主要终点
Diagnostic accuracy
状态
招募中
最后更新
2年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2023年12月15日
结束日期
2027年12月31日
最后更新
2年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Diagnostic accuracy

时间窗: through study completion, an average of 6 months

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

次要结局

  • The value to predict therapy response(through study completion, an average of 12 months)
  • FAPI expression and SUV metrics(through study completion, an average of 12 months)
  • Diagnostic accuracy comparison(through study completion, an average of 6 months)

研究点 (1)

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