Imagio Feasibility Multi-Reader, Multi-Case Study

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Device: Imagio Ultrasound
Device: Imagio (IUS+OA)
Device: Mammography

Registration Number: NCT03708393

Lead Sponsor: Seno Medical Instruments Inc.

Brief Summary: Controlled, blinded, multi-reader, multi-case study

Detailed Description: The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 155

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Imagio IUS	Mammography	Read 1 - Mammo (as available) + Imagio Ultrasound
Imagio IUS	Imagio Ultrasound	Read 1 - Mammo (as available) + Imagio Ultrasound
Imagio (IUS+OA)	Mammography	Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)
Imagio (IUS+OA)	Imagio (IUS+OA)	Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)

Primary Outcome Measures

Name	Time	Method
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1	Baseline to 12 month follow-up	Primary effectiveness endpoint was the specificity of Imagio \[IUS+OA\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for each subject (subject as own control). Results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth).

Secondary Outcome Measures

Name	Time	Method
BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months	The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads
SenoGram Performance	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months	Specificity of SenoGram estimated from cross-validation
The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)	NLR (Imagio \[IUS+OA\] vs. IUS alone); averaged across 10 readers (all readers).
Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)	pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \[IUS+OA\] vs. IUS alone; averaged across 10 readers.
SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months	SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)