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.
Public ClinicalTrials.gov record NCT00816530. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00816530
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 15,679 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 25 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2009
- Primary completion
- Nov 30, 2011
- Completion
- Nov 30, 2012
- Last update posted
- Dec 1, 2014
2009 – 2012
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Solis Women's Health | Indio | California | 92201 | — |
| Community Hospital of the Monterey Peninsula | Monterey | California | 93942 | — |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | — |
| Boca Raton Community Hospital | Boca Raton | Florida | 33486 | — |
| Radiology Regional Center | Fort Myers | Florida | 33919 | — |
| OSF Saint Francis Centers for Breast Health | Peoria | Illinois | 61615 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| Women's Imaging Centre | Lafayette | Louisiana | 70508 | — |
| Henry Ford Hospital System | Detroit | Michigan | 48202 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98111 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00816530, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2014 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00816530 live on ClinicalTrials.gov.