RecruitingNot ApplicableNCT06302595

MRI Guided Prostate Biopsy

Magnetic Resonance Imaging Guided Prostate Biopsy


Sponsor

Brigham and Women's Hospital

Enrollment

15 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of guiding prostate biopsy — one using MRI imaging combined with live ultrasound (MRI-fusion biopsy), and another where the doctor uses their memory and judgment from reviewing the MRI beforehand (cognitive biopsy). The goal is to see which method more accurately detects clinically significant prostate cancer. **You may be eligible if...** - You are over 30 years old - You have a prostate-specific antigen (PSA) level above 4 ng/mL or a nodule found on rectal exam - Your MRI shows a suspicious prostate lesion - You have signed informed consent - You have no contraindications to MRI (no pacemaker or implants incompatible with MRI) **You may NOT be eligible if...** - You cannot give informed consent - You have a pacemaker, inner ear implants, or other MRI-incompatible devices - You have active heart disease such as ongoing angina Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMRI-guided prostate biopsy using the needle holder frame.

A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT06302595


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