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MRI Guided Prostate Biopsy

Magnetic Resonance Imaging Guided Prostate Biopsy

Who can join

Ages 30 and older · Men

Inclusion 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.

Exclusion Criteria:

* 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.

About the study

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.

What is being tested

• MRI-guided prostate biopsy using the needle holder frame. (device)

Sponsor: Brigham and Women's Hospital · Participants: 15 · Started: Aug 24, 2023

Contact the study team

• Kemal Tuncali, MD · Phone: (617) 732-7631

Official record on ClinicalTrials.gov — NCT06302595

Locations in the U.S.

Conditions

• Prostate Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.