MRI Guided Prostate Biopsy

Conditions

• Suspected Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

30 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Aug 24, 2023

Status verified

Dec 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: MRI-guided prostate biopsy
  Participants who receive biopsy under MRI-guidance and a needle holder frame.

Primary Outcome Measure

Accuracy of needle placement [ Time Frame: During the MRI-guided prostate biopsy procedure ]

Central Contacts

• Kemal Tuncali, MD
  (617) 732-7631
  [email protected]

Locations (1)

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