CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study

NCT01424956 | Completed

• 1 other identifier: USI2011001
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Cancer

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)

Outcome Measures

Primary Outcomes (1)

• 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).

  Two months

Secondary Outcomes (1)

• Interpreting Physician sensitivity and specificity of breast cancer detection.

  Two months

Study Arms (1)

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)

Interventions

Automated Breast Ultrasound (ABUS) DEVICE

Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography.

Also known as: somo.V ABUS, ABUS, Whole Breast Ultrasound

Asymptomatic Women who have Dense Breast Tissue

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

17 Interpreting Physicians (Readers) qualified by training and experience, who are in breast imaging practices in the United States.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• U-Systems, Inc.: lead

Study Sites (1)

U-Systems, Inc.

Sunnyvale, California, 94085, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maryellen Giger, Ph.D.

  University of Chicago, Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 29, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (1)