Trial Outcomes & Findings for Urology of Virginia Case Series (NCT NCT03035487)
NCT ID: NCT03035487
Last Updated: 2019-05-15
Results Overview
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
COMPLETED
NA
9 participants
For each patient, keywords will be assigned within one week following the patient's procedure.
2019-05-15
Participant Flow
Participant milestones
| Measure |
Micro-ultrasound
Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
* Low resolution transrectal ultrasound examination ("LR-TRUS")
* Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsy
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Micro-ultrasound
n=9 Participants
Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
* Low resolution transrectal ultrasound examination ("LR-TRUS")
* Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: For each patient, keywords will be assigned within one week following the patient's procedure.The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
Outcome measures
| Measure |
Micro-ultrasound
n=9 Participants
Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
* Low resolution transrectal ultrasound examination ("LR-TRUS")
* Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsy
|
|---|---|
|
Keyword Description of Each Biopsy Sample
|
89 percentage significant cancers detected
|
Adverse Events
Micro-ultrasound
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place