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Optoacoustic Images Versus Imagio® Ultrasound

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

NCT04030104•Seno Medical Instruments Inc.

View on ClinicalTrials.gov

Summary

The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.

Detailed Description

This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study. Imagio® \[Ultrasound (IUS) + Optoacoustic (OA)\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol
•Patient age, indication for study entry and available medical history
•Evaluable mammograms and OA and IUS video loops and stills for each mass

Exclusion Criteria

•Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers
•Reader-02 Proficiency Test and training cases

Locations (1)

American College of Radiology Center for Research and Innovation

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

July 30, 2019

Primary Completion Date

November 3, 2019

Completion Date

November 3, 2019

Last Updated

July 12, 2021

Enrollment

480

ACTUAL participants

Conditions

Breast Cancer

Interventions

Reader Study - Imagio Ultrasound

DEVICE

Reader Study Imagio Ultrasound + Optoacoustic Imaging

DEVICE

Mammography

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optoacoustic Images Versus Imagio® Ultrasound

Inclusion Criteria

Exclusion Criteria

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