RecruitingNot Applicable

MRI Guided Prostate Biopsy

United States15 participantsStarted 2023-08-24

Plain-language 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.

Who can participate

Age range30 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Accuracy of needle placement

Timeframe: During the MRI-guided prostate biopsy procedure

Trial details

NCT IDNCT06302595

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Kemal Tuncali, MD

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

View on ClinicalTrials.gov More Suspected Prostate Cancer trials