MRI guided prostate biopsy using a specialized needle holder frame
Magnetic Resonance Imaging Guided Prostate Biopsy
This study is testing a new needle holder frame during MRI-guided prostate biopsies to see if it can help doctors take more accurate tissue samples from suspicious areas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 30 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06302595 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using a needle holder frame during MRI-guided prostate biopsy procedures to enhance the accuracy of tissue sampling from suspicious areas identified on MRI. Participants who have already undergone a standard clinical prostate MRI will have the biopsy performed using this investigational device instead of a conventional template. The procedure will be conducted under monitored anesthesia or sedation, ensuring patient comfort while the biopsy is performed. The study aims to determine if this new approach can be safely integrated into routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates include men over 30 with abnormal PSA levels or suspicious lesions on prostate MRI.
Not a fit: Patients with contraindications to MRI or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could improve the accuracy and safety of prostate biopsies, leading to better diagnosis and treatment of prostate cancer.
How similar studies have performed: Other studies have shown promising results with MRI-guided biopsy techniques, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kemal Tuncali, MD — Brigham and Women's Hospital
- Study coordinator: Kemal Tuncali, MD
- Email: ktuncali@bwh.harvard.edu
- Phone: (617) 732-7631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.