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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01424956

Run by

U-Systems, Inc.

People needed

17

Starts

2011-07-01

Expected to finish

2011-09-01

Last updated by the study team

2013-04-17

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• U-Systems, Inc. — Sunnyvale, California, United States

Full record on ClinicalTrials.gov

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