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. (somo•InSIGHT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by U-Systems, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
U-Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00816530
First received: December 30, 2008
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Device: Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Multicenter Matched-pair Clinical Study to Evaluate the Sensitivity and Specificity of ABUS and Digital X-Ray Mammography (XRM) Together as a Breast Cancer Screening Method Compared to XRM Alone in Women With >50% Parenchymal Density.

Resource links provided by NLM:


Further study details as provided by U-Systems, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20600
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
After density > 50% is confirmed by routine digital screening mammography, ABUS will be performed.
Other Names:
  • somo•v
  • somo•vu
  • somo•InSIGHT
  • ABUS
  • Automated Breast Ultrasound
  • Volumetric Breast Ultrasound
  • VBUS
  • Somography
  • Somographic Tomography

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.
    • Agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.

Exclusion Criteria:

  • ≤ 50% preliminary parenchymal density on preliminary assessment by technologist
  • Does not meet all Inclusion Criteria for Enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816530

Locations
United States, California
Solis Women's Health
Indio, California, United States, 92201
Community Hospital of the Monterey Peninsula
Monterey, California, United States, 93942
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
Radiology Regional Center
Fort Myers, Florida, United States, 33919
United States, Illinois
OSF Saint Francis Centers for Breast Health
Peoria, Illinois, United States, 61615
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Women's Imaging Centre
Lafayette, Louisiana, United States, 70508
United States, Michigan
Henry Ford Hospital System
Detroit, Michigan, United States, 48202
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Sponsors and Collaborators
U-Systems, Inc.
Investigators
Principal Investigator: Rachel F Brem, MD George Washington University
  More Information

Additional Information:
Publications:
Duffy SW, Smith RA, Gabe R, Tabár L, Yen AMF, Chen THH. Screening for breast cancer. Surg Oncol Clin N Am 2005; 14: 671-697.
Duffy SW, Tabár L, Chen THH, Smith RA, Hdmberg L, Jonsson H, Lenner P, Nyström L, Tönberg S, Frisell J, Yen AMF, Chen LS, Chiu YH, Wu CY, Wu HM, Huang CC, Warwick J, Kennetli L, Chou P. Effect of mammographic service screening on stage at presentation of breast cancers in Sweden. Cancer 2007; 109(11): 2205-2212.
Duffy SW, Tabár L, Chen THH, Smith RA, Hdmberg L, Jonsson H, Lenner P, Nyström L, Tönberg S, Frisell J, Yen AMF, Chen LS, Chiu YH, Wu CY, Wu HM, Huang CC, Warwick J, Kennetli L, Chou P. Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev 2006; 15(1): 45-51.
Duffy SW, Tabár L, Chen THH, Smith RA, Hdmberg L, Jonsson H, Lenner P, Nyström L, Tönberg S, Frisell J, Yen AMF, Chen LS, Chiu YH, Wu CY, Wu HM, Huang CC, Warwick J, Kennetli L, Chou P. Reduction in breast cancer mortality from organized service screening with mammography: 2. Validation with alternative analytic methods. Cancer Epidemiol Biomarkers Prev 2006; 15(1) 52-56.
Elmore JG, Armstrong K, Lehman CD, Fletcher SW. Screening for breast cancer. JAMA 2005; 293(10): 1245-56.
Kolb TM. Breast US for screening, diagnosing, and staging breast cancer: issues and controversies. RSNA Categorical Course in Diagnostic Radiology Physics: Advances in Breast Imaging-Physics, Technology, and Clinical Applications 2004; pp247-257.
Chen SP, Tiu CM, Chiang HR. Interpretation of Tomographic Vu in conjunction with standard Ultrasound Vu on Automated Breast Ultrasound System Study. Annual Meeting of the Asian Breast Disease Associates 2006; Chiang Mai, Thailand.
Destounis S, Young W, Murphy P, Somerville P, Seifert P, Zuley M. Initial experience of ABUS screening trial in the setting of a community based private practice (Abst.). RSNA 2006 Scientific Session.
Guingrich JA. The use of 3-D ultrasound images for the identification and diagnosis of breast cancer (Abst.). RSNA 2007 Scientific Session.

Responsible Party: U-Systems, Inc.
ClinicalTrials.gov Identifier: NCT00816530     History of Changes
Other Study ID Numbers: 2008002, WIRB® Protocol #20082014
Study First Received: December 30, 2008
Last Updated: January 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by U-Systems, Inc.:
breast
breast cancer
breast screening
breast cancer screening
breast density
dense breasts
Automated Breast Ultrasound
Ultrasonography, Mammary
Breast Neoplasms
Breast Density > 50% (BI-RADS III & IV)
ultrasound
ultrasonography
mammogram
mammography
early detection
somo v
somo•v
U-Systems

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014