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MRI Guided Prostate Biopsy

RECRUITINGN/ASponsored by Brigham and Women's Hospital
Actively Recruiting
PhaseN/A
SponsorBrigham and Women's Hospital
Started2023-08-24
Est. completion2026-06
Eligibility
Age30 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 30 Years+Sex: MALEHealthy volunteers 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.

Conditions2

CancerSuspected Prostate Cancer

Locations1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kemal Tuncali, MD617-732-7631ktuncali@bwh.harvard.edu

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