MRI Guided Prostate Biopsy

NCT06302595 | Recruiting FDA Device

• 2 other identifiers: 2022P0010935R44CA224853
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; prostate biopsy; MR-guided prostate biopsy; targeted biopsy

Outcome Measures

Primary Outcomes (1)

• Accuracy of needle placement

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

  During the MRI-guided prostate biopsy procedure

Study Arms (1)

MRI-guided prostate biopsy

EXPERIMENTAL

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

Device: MRI-guided prostate biopsy using the needle holder frame.

Interventions

MRI-guided prostate biopsy using the needle holder frame. DEVICE

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.

MRI-guided prostate biopsy

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Cancer Institute (NCI): collaborator
• Physical Sciences Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kemal Tuncali, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemal Tuncali, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 12, 2024
• Study Start: August 24, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)