Magnetic Resonance Imaging Guided Prostate Biopsy
Brigham and Women's Hospital
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.
Description
The study will be conducted during a routine MR-guided prostate biopsy procedure. The following protocol follows the workflow of the routine procedure, except that the needle holder frame is used in place of a conventional needle-guiding template. The treating physicians have decided that an MR-guided prostate biopsy is necessary under the participant's current condition. If the participant chooses to participate in this research study, the procedure will be done in an MR scanner with an investigational needle holder frame. Before the MR-guided prostate biopsy, the participant already had a s…
Eligibility
- Age range
- 30+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- DeviceMRI-guided prostate biopsy using the needle holder frame.
A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions.
Location
- Brigham and Women's HospitalBoston, Massachusetts