Clinical trial · Interventional
MRI Guided Prostate Biopsy
Magnetic Resonance Imaging Guided Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Suspected Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-guided prostate biopsy using the needle holder frame. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided prostate biopsy
- description
- Participants who receive biopsy under MRI-guidance and a needle holder frame.
- interventionNames
- Device: MRI-guided prostate biopsy using the needle holder frame.
Primary outcomes (1)
- measure
- Accuracy of needle placement
- timeFrame
- During the MRI-guided prostate biopsy procedure
- description
- The number of biopsy failures (defined as the number of needle insertions that miss the target zone defined on MRI).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available