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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).


N/A
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

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).


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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Interpreting Physician Performance In Detecting Breast Cancer

Outcome Description:

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).

Outcome Time Frame:

Two months

Safety Issue:

No

Principal Investigator

Maryellen Giger, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago, Department of Radiology

Authority:

United States: Food and Drug Administration

Study ID:

USI2011001

NCT ID:

NCT01424956

Start Date:

July 2011

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • 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)
  • Breast Neoplasms

Name

Location

U-Systems, Inc.Sunnyvale, California  94085