Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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.
研究组 & 干预措施
Experimental arm
Patients with TED will be recruited in the study.
Interventions:
Diagnostic Test: 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.
干预措施: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT (Diagnostic Test)
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)