Prostate Cancer Localization With a Multiparametric MR Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 9
- 主要终点
- Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
研究概览
简要总结
The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.
详细描述
Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the prostate.
Objective 1
To determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate cancer, by correlating:
- focal areas of low signal intensity on T2-weighted images;
- the extent and degree of deviating metabolite ratios derived from MRSI. This can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio;
- the extent and degree of apparent diffusion coefficient reduction on DWI;
- the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology.
Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The parameters from the different MR methods for a tumor focus can be correlated to the local Gleason grade of the corresponding lesion in the histopathological specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven diagnosis of adenocarcinoma of the prostate
- •Subject will sign a consent form prior to study entry
- •Radical prostatectomy and histopathological exam planned
- •The time interval between last biopsy and the MR exam must be at least 4 weeks
- •The time interval between MR exam and radical prostatectomy should not exceed 12 weeks
排除标准
- •Subjects who are unable to give valid informed consent
- •Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
- •Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy).
- •Patients under hormone deprivation therapy.
结局指标
主要结局
Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
时间窗: December 2015
次要结局
- Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer(december 2015)