Magnetic Resonance Imaging Guided Prostate Biopsy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Kemal Tuncali, MD
ktuncali@bwh.harvard.edu
(617) 732-7631
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 15
Treatments
Experimental: MRI-guided prostate biopsy
Participants who receive biopsy under MRI-guidance and a needle holder frame.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Physical Sciences Inc., National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov