Actively Recruiting

Phase Not Applicable
Age: 30Years +
MALE
NCT06302595

MRI Guided Prostate Biopsy

Led by Brigham and Women's Hospital · Updated on 2025-12-03

15

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

MRI Guided Prostate Biopsy

Who Can Participate

Age: 30Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Abnormal serum prostate-specific antigen (PSA) level (> 4 ng/mL), or a palpable prostate nodule on digital rectal exam, or suspicious lesion on prostate MRI
  • Diagnostic MRI of the prostate gland
  • Age over 30 years
  • Signed informed consent
  • No contraindications to MRI, such as no cardiac pacemaker
  • No recent or ongoing active ischemic heart disease
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

K

Kemal Tuncali, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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