Trial Outcomes & Findings for Urology San Antonio MRI/MicroUS Comparison (NCT NCT03762616)
NCT ID: NCT03762616
Last Updated: 2021-04-21
Results Overview
Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
At time of biopsy
Results posted on
2021-04-21
Participant Flow
Participant milestones
| Measure |
Micro-ultrasound Biopsy Then MRI Biopsy
Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by MRI biopsy by a second blinded operator
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
118
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Micro-ultrasound Biopsy Then MRI Biopsy
Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by MRI biopsy by a second blinded operator
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Micro-ultrasound Biopsy Then MRI Biopsy
n=118 Participants
Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by... mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
|
|---|---|
|
Age, Continuous
|
67 years
n=118 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=118 Participants
|
|
Region of Enrollment
United States
|
118 Participants
n=118 Participants
|
PRIMARY outcome
Timeframe: At time of biopsyComparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
Outcome measures
| Measure |
Micro-ultrasound Biopsy
n=118 Participants
Micro-ultrasound biopsy: Micro-ultrasound biopsy using the ExactVu micro-ultrasound system
|
MRI Targeted Biopsy
n=118 Participants
mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
|
|---|---|---|
|
Number of Participants With Clinically Significant Cancer
|
38 Participants
|
31 Participants
|
Adverse Events
Micro-ultrasound Targeted Biopsy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI Targeted Biopsy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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