Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDOPA Uptake
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Signal-to-Noise Ratio (SNR)
研究概览
简要总结
The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. The main question it aims to answer is:
Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-FDOPA and be imaged on a new type of high sensitivity PET scanner for up to 3 hours.
详细描述
This research study aims to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-FDOPA, is FDA-approved for detecting prostate cancer at standard doses.
18F-FDOPA is often found to be taken up at higher levels in Parkinsonian syndromes, neuroendocrine tumors, and gliomas. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Parkinsonian syndromes, neuroendocrine tumors, and gliomas.
Investigators will enroll individuals with and without Parkinsonian syndromes, neuroendocrine tumors, and gliomas to evaluate how ultralow dose PET imaging detects 18F-FDOPA uptake in different type of tissue.
Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years.
- •ability to provide informed consent and comply with study procedures.
- •for female participants:
- •must not be pregnant or breastfeeding.
- •negative pregnancy test required for women of childbearing potential.
排除标准
- •participants who have exceeded Nuclear Regulatory Commission regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
- •more than four prior enrollments in this study.
- •participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the pet scan
- •medication & prior treatment exclusions
- •concurrent treatments that may interfere with radiotracer uptake as determined by the Principal Investigator.
- •pregnant or breastfeeding individuals (negative pregnancy test required)
- •inability to provide informed consent
- •any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
研究组 & 干预措施
ultralow dose 18F-FDOPA imaging group
Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours
干预措施: 18F-FDOPA (Drug)
结局指标
主要结局
Signal-to-Noise Ratio (SNR)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: SNR (unitless, numeric ratio)
Contrast-to-Noise Ratio (CNR)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: CNR (unitless, numeric ratio)
Coefficient of Variation (COV)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Percentage (%)
Spatial Resolution (Full Width at Half Maximum - FWHM)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Millimeters (mm)
Target-to-Background Ratio (TBR)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Ratio (unitless numeric ratio)
Qualitative Image Quality Score (Likert Scale)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)
Inter-reader Agreement (Weighted Kappa Statistics)
时间窗: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)
次要结局
未报告次要终点
研究者
Akiva Mintz
Executive Director
Nuclear Imaging Institute