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临床试验/NCT06302595
NCT06302595招募中不适用

Magnetic Resonance Imaging Guided Prostate Biopsy

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Accuracy of needle placement

研究概览

简要总结

This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.

详细描述

The study will be conducted during a routine MR-guided prostate biopsy procedure. The following protocol follows the workflow of the routine procedure, except that the needle holder frame is used in place of a conventional needle-guiding template. The treating physicians have decided that an MR-guided prostate biopsy is necessary under the participant's current condition. If the participant chooses to participate in this research study, the procedure will be done in an MR scanner with an investigational needle holder frame.

Before the MR-guided prostate biopsy, the participant already had a standard clinical prostate MRI, the images from which will be used during the procedure.

The MR-guided prostate biopsy procedure may require monitored anesthesia or sedation. The participant will meet with the study physician prior to the biopsy procedure. The study physician will decide the type of monitored anesthesia or sedation to be used in discussion with the participant.

When undergoing a study in the MRI system, the participant will lie motionless inside the gantry of the system. Occasionally, the machine will produce a loud banging noise, as if it were being pounded from the outside with a hammer. Earplugs are available to reduce this sound level.

While the participant is in the magnet, under the anesthetic, the study physician will do the biopsy. To do this, the study physician will use a needle holder frame, which will show us where to put the needle by lining up the correct place outside on the skin or rectal wall.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Either an abnormal serum prostate-specific antigen (PSA) level (> 4ng/Ml) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion..
  • Diagnostic MRI of the prostate gland.
  • Age > 30 years
  • Signed informed consent.
  • No contra-indications to MRI, i.e. no cardiac pacemaker.
  • No recent or ongoing active ischemic heart disease.

排除标准

  • Inability to give informed consent.
  • Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips.
  • Recent or ongoing active ischemic heart disease such as recent or ongoing angina.

研究组 & 干预措施

MRI-guided prostate biopsy

Experimental

Participants who receive biopsy under MRI-guidance and a needle holder frame.

干预措施: MRI-guided prostate biopsy using the needle holder frame. (Device)

结局指标

主要结局

Accuracy of needle placement

时间窗: During the MRI-guided prostate biopsy procedure

The number of biopsy failures (defined as the number of needle insertions that miss the target zone defined on MRI).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kemal Tuncali, M.D.

Assistant Professor of Radiology

Brigham and Women's Hospital

研究点 (2)

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