Prostate Carcinoma Clinical Trial
Official title:
Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
Verified date | January 2017 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.
Status | Completed |
Enrollment | 99 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Be scheduled for a clinically indicated biopsy of the prostate - Agree to an ultrasound examination using the Aixplorer system - Sign an institutional review board (IRB) approved informed consent prior to any study procedures Exclusion Criteria: • Recent prostate biopsy within 90 days |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner | Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk. | At the time of prostate biopsy | No |
Secondary | Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy | Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient). | At the time of prostate biopsy | No |
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