A Sub-study of 18F-DCFPyL Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of dynamic whole body PET/CT imaging with participants: survey
研究概览
简要总结
Quantitative parameters obtained with dynamic whole body imaging using positron emission tomography (PET) can provide additional and complementary information to standard PET. Dynamic imaging allows for better understanding of the behavior of the radio-pharmaceutical because it can be followed over time. Thought to be difficult to perform with currently available clinical equipment that can affect the clinical workflow, it has recently shown to be feasible. We want to test the feasibility of this imaging technique and evaluate its utility in identifying lesions with three different radio-pharmaceuticals as compared to standard static PET.
This study will also determine the clinical impact of DWB PET on participant management by comparing the overall qualitative assessment performed by nuclear medicine physicians between the standard PET images and the DWB ones.
详细描述
This is a prospective single cohort study to evaluate the feasibility of dynamic whole body PET/CT in identifying and quantifying lesions where standard static PET has been negative or equivocal.
18F-FDG PET/CT - Participants that have been chosen and consented to participate in the optional DWB PET/CT scan sub-study will undergo an extra 18F-FDG PET/CT procedure. 18F-FDG is considered standard care and has been approved by Health Canada. A fasting period of 6 hours is required before the scan. Diabetic participants should withhold short acting insulin during the fasting interval, and discuss with their physician whether to reduce long acting insulin the morning of the examination. Participants will also be instructed to drink 3 to 4 glasses of water within two hours prior to their scan appointment in order to promote hydration and facilitate urinary clearance of background radiopharmaceutical.
Prior to the 18F-FDG PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician.
After providing informed written consent subjects will complete a medical history questionnaire.
The PET dynamic scan will start 30 minutes after the 18F-FDG injection. This will be followed by several whole body static acquisitions for a total scan time that will not be longer than 32 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects:
- •Meet the inclusion criteria for the appropriate main study (68Ga-DOTATOC PET/CT or 18F-DCFPyL PET/CT) or standard of care imaging.
- •Able to not use the washroom for the duration of the dynamic imaging scanning.
- •World health organization performance status 0-2
- •Able to provide written informed consent/assent (or consent by guardian for subjects <19 years)
- •Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 30 minutes and tolerating intravenous cannulation for injection.
排除标准
- •Pregnancy
- •Unable to provide written consent
- •Patients who are medically unstable ex: acute cardiac or respiratory distress, hypotensive
- •Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70cm).
结局指标
主要结局
Feasibility of dynamic whole body PET/CT imaging with participants: survey
时间窗: 24 hours
Feasibility will be measured using a survey that rates participant comfort on a scale from 1 (very uncomfortable) to 5 (very comfortable).
次要结局
- Feasibility of dynamic whole body PET/CT imaging with clinical value(2 weeks)
- Feasibility of dynamic whole body PET/CT imaging with technologists(24 hours)
- Confirm information about status of known lesions - progression or regression of lesions(5 years)