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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

MRI-guided prostate biopsy using the needle holder frame.
Device
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.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: MRI-guided prostate biopsyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Accuracy of needle placement

The number of biopsy failures (defined as the number of needle insertions that miss the target zone defined on MRI).

Time frame

During the MRI-guided prostate biopsy procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Physical Sciences Inc.

Collaborator

Source ClinicalTrials.gov

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