Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
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|ClinicalTrials.gov Identifier: NCT02524860|
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2015
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: Focal-Fusion Bx|
The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer.
A multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy.
Three prostate sampling methods will be conducted in the same session on all patients. These include:
i) Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA).
Primary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: MRI-ultrasound fusion device
Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging
Device: Focal-Fusion Bx
The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.
Other Name: MRI-ultrasound fusion device
- Proportion of biopsy cores positive for clinically significant cancer. [ Time Frame: 12 months ]
- Number of men diagnosed with clinically significant and clinically insignificant cancer. [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524860
|United States, Florida|
|Urology Treatment Center (division of 21st Century Oncology, Inc.)|
|Sarasota, Florida, United States, 34239|
|Principal Investigator:||Winston Barzell, MD||21st Century Oncology, Inc.|