MRI Guided Prostate Biopsy
Recruiting · NCT06302595 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States