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Search / Trial NCT06302595

MRI Guided Prostate Biopsy

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 8, 2024

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Prostate Cancer Prostate Biopsy Mr Guided Prostate Biopsy Targeted Biopsy

ClinConnect Summary

This clinical trial is studying a new way to perform prostate biopsies using a special device called a needle holder frame. The goal is to see if this frame can help doctors accurately and safely take samples from areas of the prostate that look suspicious on MRI scans. This study is important because it could make prostate biopsies easier and more reliable for patients suspected of having prostate cancer.

To be eligible for this trial, participants should be men over the age of 30 who have either an abnormal blood test result for prostate-specific antigen (PSA), a noticeable lump in the prostate, or a suspicious finding on a prostate MRI. They must also be able to undergo an MRI safely and give their consent to participate. If you join the study, you can expect to have a routine MRI-guided biopsy procedure using this new needle holder frame, which is being tested in place of traditional methods. It's important to know that the study is currently looking for participants, and your safety is a top priority throughout the process.

Gender

MALE

Eligibility criteria

  • 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.

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Kemal Tuncali, MD

Principal Investigator

Brigham and Women's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported