RECRUITING

MRI Guided Prostate Biopsy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Magnetic Resonance Imaging Guided Prostate Biopsy

Quick Facts

Study Start:2023-08-24
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06302595

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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..
  2. * Diagnostic MRI of the prostate gland.
  3. * Age \> 30 years
  4. * Signed informed consent.
  5. * No contra-indications to MRI, i.e. no cardiac pacemaker.
  6. * No recent or ongoing active ischemic heart disease.
  1. * Inability to give informed consent.
  2. * Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips.
  3. * Recent or ongoing active ischemic heart disease such as recent or ongoing angina.

Contacts and Locations

Study Contact

Kemal Tuncali, MD
CONTACT
(617) 732-7631
ktuncali@bwh.harvard.edu

Principal Investigator

Kemal Tuncali, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Kemal Tuncali, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-24
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2023-08-24
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Suspected Prostate Cancer