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NCT06302595Recruiting

MRI Guided Prostate Biopsy

Magnetic Resonance Imaging Guided Prostate Biopsy

Source: ClinicalTrials.gov · Last updated 3 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
15 (estimated)
First submitted
15 Feb 2024
Start date
24 Aug 2023
Primary completion date
Jun 2026
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT06302595

What you commit to

  • Study type: Interventional
  • Planned participants: 15
  • From 24 Aug 2023 to the primary completion date, Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Inability to give informed consent.

Who the study is looking for

  • 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.

Age in the registry: 30 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.