NCT00649337

Brief Summary

The purpose of this study is to determine whether addition of automated whole breast ultrasound to the usual screening mammography in a population of asymptomatic women with mammographically dense breasts will result in a significantly greater number of breast cancers discovered than would be found by mammography alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

5.5 years

First QC Date

February 25, 2008

Last Update Submit

March 27, 2008

Conditions

Breast NeoplasmsUltrasonography

Keywords

mammographyultrasoundbreast cancerscreening

Outcome Measures

Primary Outcomes (1)

  • Numbers of breast cancers detected

    One year after sonocine screening

Study Arms (1)

1

EXPERIMENTAL

Adjunct screening with sonocine

Procedure: Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography

Interventions

Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening MammographyPROCEDURE

AWBU is a computer-based system for performing and recording ultrasound scans of the whole breast. The transducer of any suitable high-resolution compound ultrasound equipment is attached to a mechanical arm guided by computer, and images are acquired in longitudinal rows, overlapping to assure complete coverage. The mechanical arm controls transducer speed and position, with a technician maintaining appropriate contact pressure and orientation vertical to the skin. Approximately 150-300 images per row are immediately displayed on the AWBU monitor, then permanently stored. The AWBU software creates a continuous ciné loop of the images, creating the appearance of real-time scanning. With spatial registration, any point on an image can be identified as a distance from the nipple in a specific radius. Image review is optimized by playback on a high-resolution monitor to allow compressed image size, 3-D reconstruction, and adjustment of contrast, brightness and review speed.

Also known as: AWBU, Sonocine
1

Eligibility Criteria

Age35 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be at least 35 years old, unless she has a strong pre-menstrual family history of breast cancer
  • have had no screening mammogram in the past 10 months
  • agree to have a screening mammogram that will not be reviewed until after a SonoCiné is performed
  • agree to have a screening mammogram in approximately one year
  • agree to answer follow up question in approximately one year
  • meet the usual criteria for breast screening (be asymptomatic of focal breast disease)
  • have no history of breast cancer for at least one year
  • agree to have both mammogram and SonoCiné if a physical finding or mammographic finding occurs within one year that requires biopsy

You may not qualify if:

  • greater than 7 cm compressed breast thickness at mammography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntington Memorial Hospital/Hill Breast Center

Pasadena, California, 91105, United States

RECRUITING

Related Publications (1)

  • Kelly KM, Dean J, Comulada WS, Lee SJ. Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol. 2010 Mar;20(3):734-42. doi: 10.1007/s00330-009-1588-y. Epub 2009 Sep 2.

    PMID: 19727744DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kevin M. Kelly, M.D.

    SonoCine, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin M Kelly, M.D.

CONTACT

626-793-6141dr.kelly@sonocine.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 25, 2008

First Posted

April 1, 2008

Study Start

January 1, 2003

Primary Completion

July 1, 2008

Study Completion

January 1, 2010

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

US(1)