Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- True negative rate
研究概览
简要总结
The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen ([Ga-68]PSMA) for characterization of prostate abnormalities.
详细描述
Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored for likelihood for malignancy using the PI-RADS version 2.1 criteria. Those with PI-RADS 3, 4 or 5 lesions or those with PI-RADS 1 or 2 lesions with clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) will be included on study. Only those receiving care at University Hospitals Cleveland Medical Center will be included into the study.
This study is to evaluate ([Ga-68]PSMA) for characterization of prostate abnormalities. For imaging, an FDA approved imaging technology, digital Positron Emission Tomography (PET/CT) will be used. The study team would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. [Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen (PSA), which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA). However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
- •Able to tolerate PET/CT scans
- •Informed consent must be given and signed
排除标准
- •Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- •Known allergy against Ga-68 PSMA
- •Prior prostate biopsy within the last 2 weeks
研究组 & 干预措施
Digital PET/CT using [Ga-68]PSMA
Following prostate Standard of Care MRI, eligible participants will receive a single injection of [Ga-68]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.
干预措施: [Ga-68]PSMA (Drug)
Digital PET/CT using [Ga-68]PSMA
Following prostate Standard of Care MRI, eligible participants will receive a single injection of [Ga-68]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.
干预措施: PET/CT imaging (Device)
结局指标
主要结局
True negative rate
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by true negative rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Specificity
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by specificity. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
False positive rate
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by false-positive rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
False negative negative rate
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by false negative rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Positive predictive value (PPV)
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by (PPV). The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Proportion of prostate lesions determined to be cancer determined by [Ga-68]PSMA compared to histopathology
时间窗: During scan, up to 35 minutes
Quantitative data collected from PET biomarker (\[Ga-68\]PSMA) uptake will be used to analyze prostate lesions for differentiation between benign prostate changes and prostate cancer. Differentiation prostate lesion by PET biomarker will be compared to histology reference standard.
True positive rate
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by true-positive rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Sensitivity
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by sensitivity. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Negative predictive value (NPV)
时间窗: During scan, up to 35 minutes
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by (NPV). The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
次要结局
- Determination of prostate lesion aggressiveness using Gleason scores(During scan, up to 35 minutes)
- Determination of prostate lesion aggressiveness using prostate grading system scores(During scan, up to 35 minutes)
- Average pre-test PSA level(During scan, up to 35 minutes)
- Proportion of metastatic lesions identified by digital PET/CT using [Ga-68]PSMA compared to reference(During scan, up to 35 minutes)
研究者
Norbert Avril, M.D.
Principal Investigator
Case Comprehensive Cancer Center