Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
NCT ID: NCT02524860
Last Updated: 2017-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-09-30
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MRI-ultrasound fusion device
Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidates for fusion biopsy
* Elevated PSA levels
* MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist)
* Subject is willing and able to read, understand and sign the Informed Consent Form document
Exclusion Criteria
* Any contraindication to a standard TRUS prostate biopsy procedure
* Refusal to sign the Informed Consent document
18 Years
80 Years
MALE
No
Sponsors
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Focal Healthcare Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Winston Barzell, MD
Role: PRINCIPAL_INVESTIGATOR
21st Century Oncology, Inc.
Locations
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Urology Treatment Center (division of 21st Century Oncology, Inc.)
Sarasota, Florida, United States
Countries
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Other Identifiers
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20150330, version 2.0
Identifier Type: -
Identifier Source: org_study_id
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