Evaluating Attenuation Correction Methods Applied to PET/MRI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
研究概览
简要总结
This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment
详细描述
PRIMARY OBJECTIVES:
I. To acquire PET/MRI scans of 100 patients which will be compared with PET/CT scans of the same subjects. The PET/CT scans will be used to provide the gold standard for evaluating the image quality and quantitative performance of the PET/MRI scans. After comparison and evaluation of the imaging capabilities and performance of the sequential PET/MRI imaging system for these 100 subjects, a second cohort of hundred consecutive subjects may be necessary and again comparisons made to the current standard of PET imaging, PET/CT. This validation of the attenuation correction methods and quantitative accuracy of the PET/MRI device compared to PET/CT will be a continuous iterative process that will result in optimized performance of the PET/MRI and will be a key step in its becoming available to other clinical research projects both within the Seidman Cancer Center as well as in other institutions.
OUTLINE:
After undergoing standard PET/CT, patients undergo PET/MRI.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients who are referred by their physician to have a clinical PET/CT will be eligible to participate in the study
- •we propose to obtain a second PET/MRI on 100 patients after their clinical PET/CT imaging that spans several disease categories and includes the following cancers: lung, colon, melanoma, head/neck and lymphoma
- •In addition to oncology patients, we anticipate imaging a subset of non-cancer patients who will also be imaged subsequent to their clinical PET/CT who will be referrals from neurology and cardiology
- •All subjects will be at least 18 years old, or if under 18, parents or guardians must give consent
- •Subjects must be stable and have experienced no adverse events from previous clinical PET/CT examination
排除标准
- •Subjects who do not meet the above inclusion criteria
- •Subjects unwilling or unable to sign the informed consent form
- •Subjects who are cognitively impaired and thus unable to give informed consent
- •Subjects unable to undergo MRI scanning due to exclusion via University Hospital Case Medical Center (UHCMC) MRI restrictions (e.g. implanted metallic or electronic devices, hip or other joint replacements, history of kidney disease, unacceptable creatinine or glomerular filtration rate [GFR], etc)
- •Patients who are pregnant
结局指标
主要结局
Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
时间窗: After PET/MRI
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
时间窗: After PET/MRI
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
时间窗: After PET/MRI
SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.
次要结局
未报告次要终点