Trials / Completed
CompletedNCT03762616
Urology San Antonio MRI/MicroUS Comparison
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Exact Imaging · Industry
- Sex
- Male
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.
Detailed description
The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Micro-ultrasound targeted biopsy | Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system |
| DIAGNOSTIC_TEST | mpMRI targeted biopsy | Multiparametric MRI targeted biopsy using software assisted MRI/US fusion |
Timeline
- Start date
- 2018-11-28
- Primary completion
- 2019-11-04
- Completion
- 2019-11-04
- First posted
- 2018-12-04
- Last updated
- 2021-04-21
- Results posted
- 2021-04-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03762616. Inclusion in this directory is not an endorsement.