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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01943916

Enrollment

2105

Registered

2013-09-17

Start date

2012-12-21

Completion date

2015-09-09

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast imaging diagnosis, breast ultrasound, Imagio, Seno Medical Instruments, Inc., Seno, opto-acoustics, OA, angiogenesis, blood map

Brief summary

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.

Detailed description

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.

Interventions

DEVICEImagio OA/US (US and OA/US)

opto-acoustic plus gray scale ultrasound

DEVICEImagio gray scale ultrasound

gray scale ultrasound alone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* female * 18 years of age or older * suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.

Exclusion criteria

* presence of a condition or impediment that may interfere with imaging. * pregnant or lactating * undergoing neoadjuvant therapy

Design outcomes

Primary

Measure	Time frame	Description
Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)	Baseline to 12 months +/- 30 days follow-up	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)

Secondary

Measure	Time frame	Description
Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)	Baseline to 12 months +/- 30 days follow-up	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 Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS)	Baseline to 12 months +/- 30 days follow-up	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 Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS)	Baseline to 12 months +/- 30 days follow-up	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)
Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)	Baseline to 12 months +/- 30 days follow-up	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
Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)	Baseline to 12 months +/- 30 days follow-up	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

Countries

United States

Participant flow

Recruitment details

Prospective controlled multi-center pivotal study of Imagio Breast Imaging System; two imaging modalities (test and control) used on each subject/mass

Pre-assignment details

Sixteen (16) centers performing Imagio ultrasound alone (IUS) and Imagio optoacoustic/ultrasound imaging (OA/US) to image breast masses, without using OA/US results for diagnosis; study compared results of each imaging modality (IUS vs. OA/US) to detect malignancy (based on biopsy diagnosis or truth panel decision as ground truth)

Participants by arm

Arm	Count
Overall 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.	1,739
Total	1,739

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Enrollment Failure	23
Overall Study	No Truth Panel Review	38
Overall Study	Pilot Phase exclusion	100
Overall Study	Protocol Deviation	1
Overall Study	Protocol Deviation No Biopsy	25
Overall Study	Quality Assurance Reader Fail	130
Overall Study	Technical Failure	39
Overall Study	Technically invalid images	10

Baseline characteristics

Characteristic	Overall Population
Age, Continuous	49.5 Years STANDARD_DEVIATION 14.7
Ethnicity (NIH/OMB) Hispanic or Latino	255 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1471 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants
Mass Diagnosis Subjects (Benign+Truth Panel Benign [TPB])	1038 Participants
Mass Diagnosis Subjects (Cancer)	652 Participants
Mass Diagnosis Subjects (Other-Truth Panel Cancer [TPC], high risk [HR])	49 Participants
Number of Masses Subjects (Benign + TPB)	1038 masses
Number of Masses Subjects (Cancer)	652 masses
Number of Masses Subjects (Other-TPC,HR)	49 masses
Race (NIH/OMB) American Indian or Alaska Native	3 Participants
Race (NIH/OMB) Asian	57 Participants
Race (NIH/OMB) Black or African American	216 Participants
Race (NIH/OMB) More than one race	81 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants
Race (NIH/OMB) White	1372 Participants
Region of Enrollment United States	1739 Participants
Sex: Female, Male Female	1739 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 1,972
other Total, other adverse events	47 / 1,972
serious Total, serious adverse events	5 / 1,972

Outcome results

Primary

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

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)