A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.

NCT00816530 | Completed

• 2 other identifiers: 2008002WIRB® Protocol #20082014
• Study Type: observational
• Target: 15,679
• Locations: 1 country
• Sites: 11

Brief Summary

Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together as part of routine screening compared to performing and reviewing results of XRM alone. Primary Objective: For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast cancer screening modality and compare it to that of XRM alone. Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue, evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS. Endpoint: Breast cancers detected by radiologists in the clinical screening setting and confirmed by pathology. Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000 women with parenchymal density \> 50% on digital x-ray mammography (XRM). Participants will receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will receive appropriate management action consistent with accepted medical standards of care. All evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be followed for one year and those who are not diagnosed with breast cancer at enrollment or during the follow-up interval must undergo an annual mammogram at study completion, the outcome of which will be recorded.

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)

• For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of XRM and ABUS together as a breast cancer screening modality and compare it to that of XRM alone.

  18 months

Secondary Outcomes (1)

• For the cohort of asymptomatic women who have dense breast tissue, evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS.

  30 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) as an adjunct to digital screening mammography

Interventions

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

After density \> 50% is confirmed by routine digital screening mammography, ABUS will be performed.

Also known as: somo•v, somo•vu, somo•InSIGHT, ABUS, Automated Breast Ultrasound, Volumetric Breast Ultrasound, VBUS, Somography, Somographic Tomography

Asymptomatic Women who have Dense Breast Tissue

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Screening to determine eligibility for enrollment will be open to women of all races and ethnicities who are asymptomatic for breast cancer and scheduled for routine screening mammography at the study site. Women younger than 25 years of age will not be eligible to participate. Potential participants must not be breastfeeding or pregnant at the time of screening and must not plan on becoming pregnant during the 12 month interval following anticipated enrollment. Patients who have had breast surgeries or interventional breast procedures in the past 12 months will also not be eligible to enter screening. Eligible women who have breast implants will be allowed to participate.

You may qualify if:

• Female
• Asymptomatic
• Prior screening mammograms, if available, exhibit history of breast density
• Not currently pregnant or breastfeeding
• Not planning to become pregnant in the following 18 months
• Age 25 or older
• No breast surgeries or interventional procedures in the past 12 months
• No history of cancer diagnosis and/or treatment in the past 12 months
• Informed Consent and Completed Participant Questionnaire
• Complete screening mammography views (CC and MLO) for one or both breasts
• \> 50% preliminary parenchymal density on preliminary assessment by technologist
• Willing to comply with study protocol and follow-up recommendations:
• If evaluation is normal, must undergo routine screening mammography in 12 months
• If evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the Investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
• Agrees to report any breast changes or symptoms to the Investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.

You may not qualify if:

• ≤ 50% preliminary parenchymal density on preliminary assessment by technologist

Sponsors & Collaborators

• U-Systems, Inc.: lead

Study Sites (11)

Solis Women's Health

Indio, California, 92201, United States

Location

Community Hospital of the Monterey Peninsula

Monterey, California, 93942, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Boca Raton Community Hospital

Boca Raton, Florida, 33486, United States

Location

Radiology Regional Center

Fort Myers, Florida, 33919, United States

Location

OSF Saint Francis Centers for Breast Health

Peoria, Illinois, 61615, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Women's Imaging Centre

Lafayette, Louisiana, 70508, United States

Location

Henry Ford Hospital System

Detroit, Michigan, 48202, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

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Related Links

• Dr. Ralph Wynn - UT Southwestern Center for Breast Care
• Dr. Mary Kay Peterson - Radiology Regional Center
• Dr. Marla Lander - The Breast Health Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel F Brem, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: January 1, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (11)