N/A
N=155
Imagio Feasibility Multi-Reader, Multi-Case Study
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03708393 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 — 80.9; 75.4; 78.7; 71.4 Percent of correct benign masses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imagio (IUS+OA) (Device); Imagio Ultrasound (Device); Mammography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Seno Medical Instruments Inc.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 |
80.9; 75.4; 78.7; 71.4; 75.8; 66.1 | — |
| SECONDARY Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1 |
2.6; 3.0 | — |
| SECONDARY BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1 |
38.5; 49.1 | — |
| SECONDARY The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1 |
.049; .094 | — |
| SECONDARY SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only |
NA; 111 | — |
| SECONDARY SenoGram Performance |
NA; 62.2 | — |
| SECONDARY SenoGram Performance |
NA; 62.2 | — |
Summary
Controlled, blinded, multi-reader, multi-case study
Eligibility Criteria
Inclusion Criteria
- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
Exclusion Criteria
- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
Data sourced from ClinicalTrials.gov (NCT03708393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.