Breast CancerReader-02NCT04030104

Optoacoustic Images Versus Imagio® Ultrasound

A study testing Reader Study - Imagio Ultrasound, Reader Study Imagio Ultrasound + Optoacoustic Imaging and Mammography in people with Breast Cancer, run by Seno Medical Instruments Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Reader Study - Imagio Ultrasound, Reader Study Imagio Ultrasound + Optoacoustic Imaging and Mammography
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2019to 3 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)
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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

American College of Radiology Center for Research and Innovation
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

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

Read the 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.

Conditions: Breast Cancer
Being tested: Reader Study - Imagio Ultrasound, Reader Study Imagio Ultrasound + Optoacoustic Imaging, Mammography
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reader Study - Imagio UltrasoundDevice
Imagio ultrasound images to be reviewed as part of Reader study
Reader Study Imagio Ultrasound + Optoacoustic ImagingDevice
Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study
MammographyDevice
Also called Mammo
Mammography as available per standard of care

Study groups in NCT04030104
Study group	Role	What they receive
Imagio IUS	Active comparator	Read 1 (Control): History + Mammogram (if available) + IUS (Imagio Ultrasound) stills and videos provided), IUS Probability of Malignancy (POM) and Breast Imaging Reporting and Data System (BI-RADS) scored and the data form then locked. Receives: Device: Reader Study - Imagio Ultrasound; Device: Mammography
Imagio (IUS+OA)	Experimental	Read 2 (Test): History + Mammogram (if available) + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). Imagio (IUS+OA) POM and Breast Imaging Reporting and Data System (BI-RADS) assigned after viewing the SenoGram® output. The dataform is locked. Receives: Device: Reader Study Imagio Ultrasound + Optoacoustic Imaging; Device: Mammography

What is being measured

The primary outcome is the main question the study is designed to answer.

Gain in Specificity at Fixed 98% Sensitivity (fSp)
Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 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). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.
Measured: Baseline to 12 months +/- 30 days follow-up

Secondary outcomes (3)

Negative Likelihood Ratio (NLR)
NLR for the Imagio IUS+OA relative to IUS alone, across all 15 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). NLR = [(1-sensitivity) / specificity].
Measured: Baseline to 12 months +/- 30 days follow-up
Positive Likelihood Ratio (PLR)
PLR for the Imagio IUS+OA relative to IUS alone, across all 15 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). PLR = [sensitivity / (1-specificity)].
Measured: Baseline to 12 months +/- 30 days follow-up
Partial Area Under the Curve (pAUC)
pAUC considers only the region of the area under the ROC curve that corresponds to clinically relevant values of sensitivity, defined as 95% to 100%, for Imagio IUS+OA vs. IUS alone, averaged across 15 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). A higher pAUC indicates better diagnostic accuracy.
Measured: Baseline to 12 months +/- 30 days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 20193 Nov 2019

First posted23 Jul 2019
Study start30 Jul 2019
Primary completion3 Nov 2019
Study completion3 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Sequential
Model 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 or the Reader-01 Feasibility Study are not eligible to participate as readers in this Pivotal Study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04030104
Sponsor's protocol ID: Reader-02 Study
Acronym: Reader-02
Status last verified: Jul 2021
First submitted: 22 May 2019
Last updated: 12 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Imagio® Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio® Ultrasound to Guide Decision to Biopsy
ClinicalTrials.gov ID: NCT04030104
Acronym / sponsor ID: Reader-02 / Reader-02 Study
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
Study start: 30 Jul 2019 (actual)
Primary completion: 3 Nov 2019 (actual)
Study completion: 3 Nov 2019 (actual)
First posted: 23 Jul 2019 (actual)
Results: Posted 4 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model 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 or the Reader-01 Feasibility Study are not eligible to participate as readers in this Pivotal Study.

Arm	Type	Receives
Imagio IUS	Active comparator	Device: Reader Study - Imagio Ultrasound, Device: MammographyRead 1 (Control): History + Mammogram (if available) + IUS (Imagio Ultrasound) stills and videos provided), IUS Probability of Malignancy (POM) and Breast Imaging Reporting and Data System (BI-RADS) scored and the data form then locked.
Imagio (IUS+OA)	Experimental	Device: Reader Study Imagio Ultrasound + Optoacoustic Imaging, Device: MammographyRead 2 (Test): History + Mammogram (if available) + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). Imagio (IUS+OA) POM and Breast Imaging Reporting and Data System (BI-RADS) assigned after viewing the SenoGram® output. The dataform is locked.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)
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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reader Study - Imagio UltrasoundImagio ultrasound images to be reviewed as part of Reader study	Device	Imagio IUS
Reader Study Imagio Ultrasound + Optoacoustic ImagingImagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study	Device	Imagio (IUS+OA)
MammographyAlso: MammoMammography as available per standard of care	Device	Imagio (IUS+OA), Imagio IUS

Primary outcome

Gain in Specificity at Fixed 98% Sensitivity (fSp)
Time frame: Baseline to 12 months +/- 30 days follow-up
Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 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). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.

3 secondary outcomes

Negative Likelihood Ratio (NLR)
Time frame: Baseline to 12 months +/- 30 days follow-up
Positive Likelihood Ratio (PLR)
Time frame: Baseline to 12 months +/- 30 days follow-up
Partial Area Under the Curve (pAUC)
Time frame: Baseline to 12 months +/- 30 days follow-up

Results and safety

Results posted to the registry on 4 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall (Subjects Randomly Selected From PIONEER-01 Study)	480	480

Primary outcome: Gain in Specificity at Fixed 98% Sensitivity (fSp)

Time frame: Baseline to 12 months +/- 30 days follow-up. Mean (95% Confidence Interval). Unit: % benign+TPB masses correctly identified

Measure	IUS Alone n = 480	Imagio (IUS+OA) n = 480
Value	38.22 (24.85 to 51.59)	47.20 (35.91 to 58.49)

IUS Alone vs Imagio (IUS+OA): p = 0.0268, Random Reader, Random Mass

Population analysed: Intent-to-diagnose (ITD)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 12 months +/- 30 days follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall (Subjects Randomly Selected From PIONEER-01 Study)	2 of 480 (0.4%)	14 of 480 (2.9%)	0 of 480

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shaan Schaeffer study director

Seno Medical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gain in Specificity at Fixed 98% Sensitivity (fSp) (time frame: Baseline to 12 months +/- 30 days follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.