Recruiting

MRI Guided Biopsy

Sponsor:

Brigham and Women's Hospital

Code:

NCT06302595

Conditions

Suspected Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 30+

Healthy Volunteers: Not accepted

Interventions

MRI-guided prostate biopsy using the needle holder frame.

Study Details

Brief summary:

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

Study ID

NCT06302595

Start date

Aug 24, 2023

Status verified date

Dec, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: MRI-guided prostate biopsy

Participants who receive biopsy under MRI-guidance and a needle holder frame.

Interventions

MRI-guided prostate biopsy using the needle holder frame.

A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions.

Primary outcome measure

  • Accuracy of needle placement [ Time Frame: During the MRI-guided prostate biopsy procedure ]

Central Contacts and Locations

Central contacts

Kemal Tuncali, MD

(617) 732-7631ktuncali@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kemal Tuncali, MD

617-732-7631ktuncali@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Keywords

  • prostate cancer
  • prostate biopsy
  • MR-guided prostate biopsy
  • targeted biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-12-03.