Breast CancerNCT01424956
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
An observational study of Breast Cancer, run by U-Systems, Inc. at 1 site in United States.
Trial summary
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Automated Breast Ultrasound (ABUS)
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 17 Interpreting Physicians (Readers) qualified by training and experience, who are in breast imaging practices in the United States.
Who may be able to join
- Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
- Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
- Currently meets the minimum Mammography Interpretation requirements per MQSA
- Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
- Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
- Successful completion of ABUS training
Who cannot join
- Does not meet definition of Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
- Does not meet requirements of Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
- Does not meet requirements of minimum Mammography Interpretation requirements per MQSA
- Does not meet requirements of Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
- Does not meet requirements of Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
- Does not meet requirements of successful completion of ABUS training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Determine the Impact on Reader Performance, as Defined by the Area Under the Receiver Operating Characteristic Curve, When Automated Breast Ultrasound and a Screening Mammogram Are Combined, Compared to a Screening Mammogram Alone in Asymptomatic Women With >50% Parenchymal Density and a Screening Mammogram Assigned a BI-RADS Assessment Category 1 (Negative) or 2 (Normal With Benign Findings).
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women with >50% parenchymal density and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
The effect of the improved Reader performance is illustrated by plotting the ROC curves for XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM, the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null and alternative hypotheses can be formally expressed as follows:
Read more
H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2.
HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader performance will be changed with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05 for a two-sided test.
Read the detailed description
The Clinical Retrospective Reader Study is an observational case-controlled, multi-reader multi-case Receiver Operating Characteristic (ROC) study involving approximately 16 Interpreting Physicians (Readers) and approximately 200 breast screening cases which will be reviewed and of those, 164 breast screening cases will be included in the primary data analysis. All primary data analysis cases will consist of screening mammogram and Automated Breast Ultrasound image readings from the same asymptomatic females with >50% parenchymal density for whom the screening mammogram was assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
The Readers will review a total of 200 cases: the Non-Cancer Case Set, the Cancer Case Set, and additional Control and Supplemental Case Sets. These cases will be randomized during the reading session so each Reader will review the entire Case Set in a unique order.
The primary Receiver Operating Characteristic analysis will be performed on the Readers' Likelihood of Malignancy (LOM) ratings from their initial review of the screening mammogram alone and their final review of the screening mammogram and Automated Breast Ultrasound for the Non-Cancer Case Set and Cancer Case Set.
- Conditions
- Breast Cancer
- Being tested
- Automated Breast Ultrasound (ABUS)
- Keywords
- breast, breast cancer, breast screening, breast cancer screening, ultrasound, ultrasonography, mammogram, mammography, breast density, dense breasts, early detection, somo v, somo•v, U-Systems, Automated Breast Ultrasound, Ultrasonography, Mammary, Breast Neoplasms, Breast Density > 50% (BI-RADS III & IV)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Breast Ultrasound (ABUS)Device
Also called somo.V ABUS, ABUS, Whole Breast Ultrasound
Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Women who have Dense Breast Tissue | Women who have no signs or symptoms of breast cancer who have > 50% parenchymal density on mammography. Receives: Device: Automated Breast Ultrasound (ABUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpreting Physician Performance In Detecting Breast Cancer
To determine the impact on Interpreting Physician (Reader) Performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic (ROC) Curve (AUC), when ABUS and XRM are combined (XRM+ABUS), compared to XRM Alone in asymptomatic women with >50% parenchymal density (BI-RADS Composition/Density rating of 3 or 4) and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
Measured: Two months
Secondary outcomes (1)
Interpreting Physician sensitivity and specificity of breast cancer detection.
Reader sensitivity and specificity when XRM+ABUS are combined compared to XRM Alone for two different combinations of cut points.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- U-Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maryellen Giger, Ph.D., Principal investigator, University of Chicago, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424956
- Sponsor's protocol ID
- USI2011001
- Status last verified
- Apr 2013
- First submitted
- 25 Aug 2011
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Impact on Reader Performance, as Defined by the Area Under the Receiver Operating Characteristic Curve, When Automated Breast Ultrasound and a Screening Mammogram Are Combined, Compared to a Screening Mammogram Alone in Asymptomatic Women With >50% Parenchymal Density and a Screening Mammogram Assigned a BI-RADS Assessment Category 1 (Negative) or 2 (Normal With Benign Findings).
- ClinicalTrials.gov ID
- NCT01424956
- Acronym / sponsor ID
- USI2011001
- Conditions
- Breast Cancer
- Keywords
- breast, breast cancer, breast screening, breast cancer screening, ultrasound, ultrasonography, mammogram, mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- U-Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women with >50% parenchymal density and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
The effect of the improved Reader performance is illustrated by plotting the ROC curves for XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM, the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null and alternative hypotheses can be formally expressed as follows:
H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2.
HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader performance will be changed with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05 for a two-sided test.
Detailed description
The Clinical Retrospective Reader Study is an observational case-controlled, multi-reader multi-case Receiver Operating Characteristic (ROC) study involving approximately 16 Interpreting Physicians (Readers) and approximately 200 breast screening cases which will be reviewed and of those, 164 breast screening cases will be included in the primary data analysis. All primary data analysis cases will consist of screening mammogram and Automated Breast Ultrasound image readings from the same asymptomatic females with >50% parenchymal density for whom the screening mammogram was assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
The Readers will review a total of 200 cases: the Non-Cancer Case Set, the Cancer Case Set, and additional Control and Supplemental Case Sets. These cases will be randomized during the reading session so each Reader will review the entire Case Set in a unique order.
The primary Receiver Operating Characteristic analysis will be performed on the Readers' Likelihood of Malignancy (LOM) ratings from their initial review of the screening mammogram alone and their final review of the screening mammogram and Automated Breast Ultrasound for the Non-Cancer Case Set and Cancer Case Set.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Women who have Dense Breast Tissue | – | Device: Automated Breast Ultrasound (ABUS)Women who have no signs or symptoms of breast cancer who have > 50% parenchymal density on mammography. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 17 Interpreting Physicians (Readers) qualified by training and experience, who are in breast imaging practices in the United States.
Key inclusion criteria (6 listed)
- Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
- Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
- Currently meets the minimum Mammography Interpretation requirements per MQSA
- Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
- Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
Key exclusion criteria (6 listed)
- Does not meet definition of Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
- Does not meet requirements of Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
- Does not meet requirements of minimum Mammography Interpretation requirements per MQSA
- Does not meet requirements of Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
- Does not meet requirements of Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
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 |
|---|---|---|
| Automated Breast Ultrasound (ABUS)Also: somo.V ABUS, ABUS, Whole Breast UltrasoundAutomated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography. | Device | Asymptomatic Women who have Dense Breast Tissue |
Primary outcome
Interpreting Physician Performance In Detecting Breast Cancer
Time frame: Two months
To determine the impact on Interpreting Physician (Reader) Performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic (ROC) Curve (AUC), when ABUS and XRM are combined (XRM+ABUS), compared to XRM Alone in asymptomatic women with >50% parenchymal density (BI-RADS Composition/Density rating of 3 or 4) and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
1 secondary outcome
Interpreting Physician sensitivity and specificity of breast cancer detection.
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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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.
Maryellen Giger, Ph.D. principal investigator
University of Chicago, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by U-Systems, 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 6 inclusion and 6 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 17 Apr 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interpreting Physician Performance In Detecting Breast Cancer (time frame: Two months). 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 17 Apr 2013.