Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan
研究概览
简要总结
This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.
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
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
- •Primary prostate cancer proven by sextant prostate biopsy
- •Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
- •Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
- •In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
- •ECOG status of 0 or 1 Pt > 18 yrs of age
排除标准
- •Definitive or concomitant therapeutic intervention within the interval of study intervention
- •Prior pelvic therapeutic radiation
- •Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
- •Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
- •Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products
结局指标
主要结局
Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan
时间窗: Within on month of scan and corresponding MRI
Detection of PSMA antibody (ProstaScint) uptake patterns measured by the new transrectal compact gamma camera (Proxiscan) will be compared to the anatomic biopsy reports along with Magnetic Resonance Imaging (MRI) and conventional ProstaScint (Single Photon Emission Computed Tomography) SPECT imaging results. All imaging and biopsy results performed within one month will be used for this investigation
次要结局
未报告次要终点