Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The number of prostate patients with comedo-type necrosis.
研究概览
简要总结
Management of prostatic carcinoma varies according to stage of disease. Trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. Methods to improve pre-operative tumor localization and grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area of research but requires further validation.
High grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI.
Detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.
详细描述
High grade (Gleason pattern 5) tumors can undergo comedo-type necrosis producing malignant calcifications which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcifications in areas of Gleason pattern 5 tumor will improve the accuracy of pre-operative localization and grading in prostatic carcinoma.
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
- Single (Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
- •Patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification
排除标准
- •Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
结局指标
主要结局
The number of prostate patients with comedo-type necrosis.
时间窗: up to 4 weeks
Two radiologists will review the MRI and CT examinations separated by a 4 week interval to decrease recall bias. Further, readers will review the 3 additional gradient echo pulse sequences independently at 3 different MRI reading sessions, also separated by 4 weeks, in order to compare the accuracy from each pulse sequence and to reduce recall bias.
次要结局
- The number of other features measured on MRI.(up to 4 weeks)