Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI
研究概览
简要总结
Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this PET tracer, including identification of subclinical disease in latently infected individuals. This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI
时间窗: Within 28 days of commencing TB treatment
次要结局
- Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.(Within 28 days of commencing TB treatment)
- Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology(Over 90 minutes from injection of tracer)