Imagio Feasibility Multi-Reader, Multi-Case Study

Seno Medical Instruments Inc.155 enrolled

Overview

Controlled, blinded, multi-reader, multi-case study

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

155

Conditions

Breast Cancer

Interventions

Imagio (IUS+OA)DEVICE

The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study

Imagio UltrasoundDEVICE

Imagio ultrasound images to be reviewed as part of the reader study

MammographyDEVICE

Mammography images as available per standard of care

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

American College of Radiology

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1

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).

Time frame: Baseline to 12 month follow-up

Secondary Outcomes

Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1

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.

Time frame: 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)

BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1

The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads

Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1

NLR (Imagio \[IUS+OA\] vs. IUS alone); averaged across 10 readers (all readers).

Time frame: 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)

SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only

Data from ClinicalTrials.gov

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