NCT01007214终止不适用
Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.
研究概览
简要总结
Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy.
详细描述
The objective of this study is to determine the accuracy of HIT (Hybrid Imaging Technology) guided biopsies for mapping tumor foci with men undergoing prostatectomy. Using a prostate hybrid imaging technology (HIT) which fuses a previously obtained endorectal MR image to transrectal ultrasound (TRUS) image to allow identification and biopsy of tumors by MR imaging in real time. We hypothesis that HIT guided biopsies will accurately localize the foci of prostate cancer.
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
- •Patients must have histologically confirmed diagnosis of prostate cancer
- •Patients must have elected to undergo radical prostatectomy using an open, laparoscopic or robotic approach
- •Patients must be at least 18 years of age and able to provide written informed consent.
- •No history of radiotherapy, chemotherapy or hormone therapy within 6 months of surgery
- •Primary tumor must be amenable to surgical removal for curative intent
- •Patients must have ECOG-performance status 0 or 1 (appendix II)
- •Patients must have no history of rectal or anal disease.
- •Patients must have adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT])≤2.5x local laboratory upper limit of normal (ULN), or AST and ALT ≤5x ULN if liver function abnormalities are due to underlying malignancy
- •Total serum bilirubin ≤1.5 x ULN
- •Absolute neutrophil count(ANC)≥1,500/microL
- •Platelets≥lOO,OOO/microL
- •Hemoglobin≥9.0 g/dL
- •Serum calcium≤10.2mg/dL (correct for low albumin if necessary; calcium + (normal albumin - serum albumin)x 0.8)
- •Patients must have serum creatinine<2 mg/dL or serum creatinine clearance (CrCl)>40ml/min(CrCl= Wt(kg)x(140-age)*/72xCr. level,*female x 0.85)
- •Inclusion of minorities:
- •Members of all races and ethnic groups are eligible for this trial. Women and children are not eligible since prostate cancer is not diagnosed in these groups.
排除标准
- 未提供
结局指标
主要结局
Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.
时间窗: Six years
次要结局
未报告次要终点
研究者
研究点 (2)
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