Imagio Feasibility Multi-Reader, Multi-Case Study

Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Imagio Ultrasound; Device: Mammography; Device: Imagio (IUS+OA)

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

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • American College of Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Imagio IUS; Read 1 - Mammo (as available) + Imagio Ultrasound	Device: Imagio Ultrasound; Imagio ultrasound images to be reviewed as part of the reader study; Device: Mammography; Mammography images as available per standard of care; Other Names: Mammo
Experimental: Imagio (IUS+OA); Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)	Device: Mammography; Mammography images as available per standard of care; Other Names: Mammo; Device: Imagio (IUS+OA); The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	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	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)	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
SenoGram Performance	Sensitivity of SenoGram estimated from cross-validation - 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
SenoGram Performance	Specificity of SenoGram estimated from cross-validation	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

Collaborators and Investigators

• Sponsor: Seno Medical Instruments Inc.
• Collaborators: American College of Radiology
• Investigators: Study Director: A. Thomas Stavros, MD, Seno Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): December 9, 2018
• Study Completion (Actual): December 9, 2018

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Reader-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes