CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
|ClinicalTrials.gov Identifier: NCT01424956|
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : April 17, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Automated Breast Ultrasound (ABUS)|
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 Type :||Observational|
|Actual Enrollment :||17 participants|
|Observational Model:||Case Control|
|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).|
|Study Start Date :||July 2011|
|Primary Completion Date :||August 2011|
|Study Completion Date :||September 2011|
Asymptomatic Women who have Dense Breast Tissue
Women who have no signs or symptoms of breast cancer who have > 50% parenchymal density on mammography.
Device: Automated Breast Ultrasound (ABUS)
Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography.
- 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).
- Interpreting Physician sensitivity and specificity of breast cancer detection. [ Time Frame: Two months ]Reader sensitivity and specificity when XRM+ABUS are combined compared to XRM Alone for two different combinations of cut points.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424956
|United States, California|
|Sunnyvale, California, United States, 94085|
|Principal Investigator:||Maryellen Giger, Ph.D.||University of Chicago, Department of Radiology|