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临床试验/NCT01985932
NCT01985932已完成不适用

A Prospective Study Evaluating Non-Endorectal Coil Functional MRI Identification of Intraprostatic Tumor During Radiation Treatment Planning

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Number of Participants With Adverse Events

研究概览

简要总结

This study is being done to evaluate the use of MRI during radiation treatment planning to identify areas of tumor within the prostate to aid in future treatment planning and targeting of prostate cancer. This study will be conducted at the University of Pennsylvania Health System. The study is projected to run for 18 months. Subjects will be male 18 or older with a prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.

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

入选标准

  • Age 18 or older
  • Biopsy proven prostate cancer without evidence of metastatic disease
  • Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers.
  • Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy
  • Subject capable of giving informed consent for standard external beam RT and for the study.
  • No current contraindication that would prevent MRI or gadolinium contrast.

排除标准

  • Metastatic disease
  • Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy
  • Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim
  • Contraindication that would prevent MRI or gadolinium contrast
  • GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.

结局指标

主要结局

Number of Participants With Adverse Events

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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