Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Imagio OA/US (gray scale and opto-acoustic)

Imagio OA/US (US and OA/US)

Imagio gray scale ultrasound

This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who will read the Imagio gray-scale images vs the Imagio OA/US images.

Imagio is a multi-modality device, comprised of one probe with the ability to image with diagnostic gray scale (B mode) ultrasound alone and gray scale in conjunction with OA together in a six up image.

The PIONEER-01 Study of the Imagio Breast Imaging System

A Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists

Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in 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)

Sensitivity difference for Imagio OA/US Imagio relative to IUS, across all 7 independent readers; both imaging modalities used in 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)

Specificity for each imaging modality, Imagio OA/US (Imagio) and IUS, across all 7 independent readers; both imaging modalities used in 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)

Sensitivity for each imaging modality, Imagio OA/US and IUS, across all 7 independent readers; both imaging modalities used in 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)

Percentage of reads where breast mass was downgraded from one BI-RADS (BR) category to a lower BR category on the basis of additional information from the Imagio OA/US imaging modality compared to IUS, includes reads of each of 7 independent readers; both imaging modalities used in 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). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5

Percentage of reads where breast mass was upgraded from one BI-RADS (BR) category to a higher BR category on the basis of additional information from the Imagio optoacoustic plus grayscale (OA/US) imaging modality compared to Imagio grayscale (IUS), includes reads of each of 7 independent readers; both imaging modalities used in 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). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5

Seno Medical Instruments Inc.

Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).

Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore safety data are for overall safety population only.

Safety Population

Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore baseline data are for overall population only.

Overall Population

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Subjects (Benign + TPB)

Subjects (Cancer)

Subjects (Other-TPC,HR)

Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects.

Number of Masses

Subjects (Benign+Truth Panel Benign [TPB])

Subjects (Other-Truth Panel Cancer [TPC], high risk [HR])

Measure Description: Mass diagnosis by biopsy result or Truth Panel decision on benign status

Mass Diagnosis

Shaan Schaeffer, VP Clinical Operations

Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.

Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)

Each subject served as her own control, with imaging of each mass by both the test and control modalities. Sensitivity difference is a single measure for the overall ITD population.

Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)

Imagio Ultrasound (IUS) gray-scale ultrasound imaging of mass

Imagio Ultrasound (IUS) Gray-scale Ultrasound Imaging of Mass

Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass

OA/US

Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS)

Imagio optoacoustic imaging plus grayscale imaging of mass

Imagio (OA/US)

Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS)

Each subject served as her own control, with imaging of each mass by both the test and control modalities. Downgrades are based on Imagio optoacoustic plus grayscale (OA/US) relative to Imagio grayscale (IUS), thus this is a single measure for the over all ITD population.

Overall ITD Population

Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)

Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)

Each subject served as her own control, with imaging of each mass by both the test Imagio (IUS+OA) and control (IUS only) modalities; therefore baseline data are not broken into each arm - test and control due the numbers being the same for each arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The PIONEER-01 Study of the Imagio Breast Imaging System	NCT01943916	Breast Cancer	Imagio OA/US (U... Imagio gray sca...	18 Years -	Seno Medical Instruments Inc.
The PIONEER-01 Study of the Imagio Breast Imaging System	NCT01943916	Breast Cancer	Imagio OA/US (U... Imagio gray sca...	18 Years -	Seno Medical Instruments Inc.

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