Investigation of the Magnitude of Uptake, Retention, and Spatial Distribution Pattern of 18F-Choline in Comparison With MRI and Histology Obtained From Prostate Cancer Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Evaluation whether the odds of primary Gleason ≥ 3+4 are greater for image-guided biopsy (based on parametric PET/MRI) than for non-image-guided (standard) biopsy.
研究概览
简要总结
This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.
详细描述
This is an explorative diagnostic basic research study to assess the value of 18F-choline PET/CT and multi-sequence MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients will receive image-guided (targeted) prostate biopsies and metabolomic profiling of prostate biopsy tissues to evaluate underlying metabolic changes in comparison with pathological Gleason grading.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 40 years of age or older scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A)
- •Males 40 years of age or older with known (biopsy-confirmed) primary adenocarcinoma of the prostate undergoing active surveillance scheduled for prostate biopsy (population group B)
排除标准
- •Androgen ablation (hormone treatment) within the last 3 months
- •Prostate biopsy within 6 weeks prior to PET or MRI imaging
- •Active inflammatory bowel disease within the last 6 months
- •Acute prostatitis within the last 6 months
- •A non-urologic bacterial infection requiring active treatment with antibiotics
- •Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
- •Previous radiation treatment of the pelvis
- •Symptomatic distal rectal stenosis
- •Known hypersensitivity to glucagon
- •Pheochromocytoma, insulinoma or galactosemia
- •Insulin-dependent diabetes
研究组 & 干预措施
Prostate Cancer Imaging
Subjects will receive multi-sequence Magnetic Resonance Imaging (MRI) of the prostate and pelvis. This scan will take approximately 90 minutes.
In addition, a 18F-Choline PET/CT(Positron emission tomography/computed tomography) scan of the abdomen and pelvis is performed. This scan will take about 30 minutes. Subjects may receive an additional 30 minute scan, if needed.
Patients participating in an active surveillance program at the University of Michigan may receive yearly imaging followed by a prostate biopsy procedure.
干预措施: Prostate Cancer Imaging (Procedure)
结局指标
主要结局
Evaluation whether the odds of primary Gleason ≥ 3+4 are greater for image-guided biopsy (based on parametric PET/MRI) than for non-image-guided (standard) biopsy.
时间窗: 4 years
次要结局
未报告次要终点
研究者
Morand Piert, MD
Principal Investigator
University of Michigan