MRI Guided Prostate Biopsy
ConditionSuspected Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30+
SponsorBrigham and Women's Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MRI-guided prostate biopsy using the needle holder frame.
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Physical Sciences Inc.
Collaborator
Source ClinicalTrials.gov