Breast CancerNCT03708393
Imagio Feasibility Multi-Reader, Multi-Case Study
A study testing Imagio (IUS+OA), Imagio Ultrasound and Mammography in people with Breast Cancer, run by Seno Medical Instruments Inc. at 1 site in United States.
Trial summary
Controlled, blinded, multi-reader, multi-case study 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?
- Imagio (IUS+OA), Imagio Ultrasound and Mammography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2018to 9 Dec 2018
- 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
- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
Who cannot join
- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
Trial locations and contacts
1 site in 1 country.
United States1 site
American College of Radiology
Philadelphia, Pennsylvania, 19103
About this study
Official title: 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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Imagio (IUS+OA), Imagio Ultrasound, 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.
Imagio (IUS+OA)Device
The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study
Imagio UltrasoundDevice
Imagio ultrasound images to be reviewed as part of the reader study
MammographyDevice
Also called Mammo
Mammography images as available per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Imagio IUS | Active comparator | Read 1 - Mammo (as available) + Imagio Ultrasound Receives: Device: Imagio Ultrasound; Device: Mammography |
| Imagio (IUS+OA) | Experimental | Read 2 - Mammo (as available) + (Imagio Ultrasound + OA) Receives: Device: Imagio (IUS+OA); Device: Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 12 month follow-up
Secondary outcomes (6)
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.
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start13 Nov 2018
- Primary completion9 Dec 2018
- Study completion9 Dec 2018
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 5-12 independent readers depending on qualifications and availability. Imagio (IUS+OA) Training to be completed prior to any reads taking place. Read 1 is immediately followed by Read 2 within the same read session. Read 1 (Control): Mammogram (if available) + History + IUS (stills and videos provided), IUS Probability of Malignancy (POM) and BI-RADS scored and the data form locked. Read 2 (Test): Mammogram (if available) + History + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). An interim IUS POM and BI-RADS is recorded as well as a combined Imagio (IUS+OA) POM and BIRADS Pre and Post SenoGram on separate data forms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seno Medical Instruments Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Responsible party
- Sponsor
- Investigators
- A. Thomas Stavros, MD, Study director, Seno Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708393
- Sponsor's protocol ID
- Reader-01
- Status last verified
- Jul 2021
- First submitted
- 28 Sep 2018
- Last updated
- 6 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy
- ClinicalTrials.gov ID
- NCT03708393
- Acronym / sponsor ID
- Reader-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 9 Dec 2018 (actual)
- Study completion
- 9 Dec 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Controlled, blinded, multi-reader, multi-case study
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 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 5-12 independent readers depending on qualifications and availability. Imagio (IUS+OA) Training to be completed prior to any reads taking place. Read 1 is immediately followed by Read 2 within the same read session. Read 1 (Control): Mammogram (if available) + History + IUS (stills and videos provided), IUS Probability of Malignancy (POM) and BI-RADS scored and the data form locked. Read 2 (Test): Mammogram (if available) + History + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). An interim IUS POM and BI-RADS is recorded as well as a combined Imagio (IUS+OA) POM and BIRADS Pre and Post SenoGram on separate data forms.
| Arm | Type | Receives |
|---|---|---|
| Imagio IUS | Active comparator | Device: Imagio Ultrasound, Device: MammographyRead 1 - Mammo (as available) + Imagio Ultrasound |
| Imagio (IUS+OA) | Experimental | Device: Imagio (IUS+OA), Device: MammographyRead 2 - Mammo (as available) + (Imagio Ultrasound + OA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
Key exclusion criteria (1 listed)
- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
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 |
|---|---|---|
| Imagio (IUS+OA)The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study | Device | Imagio (IUS+OA) |
| Imagio UltrasoundImagio ultrasound images to be reviewed as part of the reader study | Device | Imagio IUS |
| MammographyAlso: MammoMammography images as available per standard of care | Device | Imagio (IUS+OA), Imagio IUS |
Primary outcome
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1
Time frame: Baseline to 12 month follow-up
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).
6 secondary outcomes
Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
A. Thomas Stavros, MD 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?
A study testing Imagio (IUS+OA), Imagio Ultrasound and Mammography in people with Breast Cancer, run by Seno Medical Instruments Inc. at 1 site in United States.
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 1 inclusion and 1 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 6 Aug 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 6 Aug 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?
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 (time frame: Baseline to 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2021.