MRI Guided Prostate Biopsy with a Needle Holder Frame

This study is testing a new tool called a needle holder frame, which helps guide the needle during an MRI-guided prostate biopsy. The goal is to see if this frame can accurately collect tissue samples from areas in your prostate that look suspicious on an MRI. If it works well, it could make routine biopsies safer and more precise. You might be eligible if you are a man over 30 with a high PSA (prostate-specific antigen) level, a suspicious lump found during an exam, or a suspicious area on a prostate MRI. The study will enroll about 15 participants and is currently unclear on its recruitment status. Success for this study means the needle holder frame accurately places the biopsy needle.

Study design
This is an interventional study involving about 15 male participants. It compares the use of a needle holder frame to a conventional needle-guiding template during a routine MRI-guided prostate biopsy.
What's involved
You would undergo a routine MRI-guided prostate biopsy procedure using the investigational needle holder frame. This involves lying still in an MRI scanner, potentially with anesthesia or sedation, while tissue samples are taken.
Compensation
Not stated in the trial record.
Follow-up
Accuracy of needle placement is measured during the MRI-guided prostate biopsy procedure. No further follow-up is specified.

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NCT06302595

MRI Guided Prostate Biopsy

Recruiting
NAAges 30+InterventionalDevice feasibility
Brigham and Women's Hospital
~15 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:MRI-guided prostate biopsy using the needle holder frame.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of needle placement
Measured over During the MRI-guided prostate biopsy procedure
Suspected Prostate Cancer
1 sites across 1 states
Massachusetts1
  • Kemal Tuncali, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

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Eligibility criteria

Inclusion

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

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.
  • Accuracy of needle placementDuring the MRI-guided prostate biopsy procedure

    The number of biopsy failures (defined as the number of needle insertions that miss the target zone defined on MRI).