MRI Guided Prostate Biopsy

Description

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.

Conditions

Suspected Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

Magnetic Resonance Imaging Guided Prostate Biopsy

MRI Guided Prostate Biopsy

Condition
Suspected Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Kemal Tuncali, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2024-08-31