Evaluation of MRI With Dixon Based Sequences in the Detection of Prostate Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Detection of at least one or more prostate lesions with Dixon sequencing
研究概览
简要总结
This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.
II. Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement.
SECONDARY OBJECTIVES:
I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy.
- •Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam.
- •Patients who have signed their informed consent form to undergo the study.
排除标准
- •Known prior hormone ablation or radiation therapy (pelvic or prostate).
- •Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance.
- •Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).
研究组 & 干预措施
Diagnostic (standard MRI, Dixon MRI)
Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.
干预措施: Dixon MRI (Procedure)
Diagnostic (standard MRI, Dixon MRI)
Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Detection of at least one or more prostate lesions with Dixon sequencing
时间窗: through study completion, an average of 1 year
Will evaluate and compare the accuracy of Dixon based sequencing to the conventional T2 weighted sequencing for detection of intraprostatic tumor and extraprostatic tumor extension. Lesions will be within any of six regions of the prostate: left apex, left mid, left base, right apex, right mid, and right base. The relative sensitivity and specificity of the two sequencing methods will be compared using an adjusted McNemar's test for clustered data where clusters consist of the matched pairs of within patient-zone observations. The primary analysis will also provide 95% confidence intervals for marginal sensitivity and specificity using a generalized linear mixed model.
次要结局
未报告次要终点