Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
研究概览
详细说明
Granulomas, the hallmark of tuberculosis (TB) infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, may be able to identify these pulmonary granulomas. Although currently used for other medical indications, 68Ga-DOTANOC PET scanning has not previously been used to detect TB lesions.
This is a pilot study which aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis. The 68Ga-DOTANOC PET scan and 'standard' 18F-fludeoxyglucose (FDG) PET scan will be compared to enable analysis of differences in uptake between these tracers in terms of number, size and distribution of lesions.
Demonstrating the clinical utility of 68Ga-DOTANOC in active pulmonary TB is necessary prior to using this PET tracer to further explore other potential uses in TB such as identifying individuals with latent TB who are at risk of progressing to active TB, measuring therapeutic response to TB treatment and identifying extrapulmonary lesions.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Singapore、新加坡
- 招聘中
- National University Hospital
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接触：
- Claire Naftalin
- 电话号码：(65) 6601 5373
- 邮箱：claire_naftalin@nuhs.edu.sg
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Singapore、新加坡
- 招聘中
- Tan Tock Seng Hospital
-
接触：
- Sonny YT Wang
- 电话号码：(65) 6511 5131
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 21 years and above
- Willing to comply with the study visits and procedures
- Willing and able to provide written informed consent
- Clinical diagnosis of pulmonary TB with characteristic symptoms and compatible X-ray findings plus microbiological confirmation with one or more of (i) Acid fast bacilli (AFB) smear-positive or (ii) molecular test positive or (iii) TB culture positive
- Not on TB treatment or have completed less than 28 days of TB treatment
Exclusion Criteria:
- Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
- Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
- Known chronic kidney disease
- Occupation involving substantial exposure to radiation
- Malignancy requiring chemotherapy or radiation
- Women who are currently pregnant or breastfeeding
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：68Ga-DOTANOC PET/MRI
Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI
大体时间：Within 28 days of commencing TB treatment
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Within 28 days of commencing TB treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.
大体时间：Within 28 days of commencing TB treatment
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Different uptake values between and within the pulmonary lesions will be measured and compared between the 2 tracers.
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Within 28 days of commencing TB treatment
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Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology
大体时间：Over 90 minutes from injection of tracer
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The net tracer uptake rate for 68Ga-DOTANOC (Ki) will be derived from kinetic analysis in combination with dynamic imaging and the relationship between SUV and Ki.
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Over 90 minutes from injection of tracer
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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