Urology of Virginia Case Series
Completed · Not applicable
Conditions studied: Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm
In brief
The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer. The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI). These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy. In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.
Key facts
- Study ID
- NCT03035487
- Run by
- Exact Imaging
- People needed
- 9
- Starts
- 2016-12-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2019-05-15
Who can join
Age: 40 and older, up to 79. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
- PSA<50
- Clinical stage < cT2c
You may not qualify if…
- Patients will be excluded from being included in the investigation if any of the following is true:
- Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
- Men with known prostate volume (from prior imaging) of > 60cc
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
- Men who have contraindications to MRI or gadolinium chelate contrast
Where it is running
- Urology of Virginia — Virginia Beach, Virginia, United States
Full record on ClinicalTrials.gov
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