Recruiting

Breast Cancer Detection

Sponsor:

SonoCine, Inc.

Code:

NCT00649337

Conditions

Breast Neoplasms

Ultrasonography

Eligibility Criteria

Sex: Female

Age: 35 - 70+

Healthy Volunteers: Accepted

Interventions

Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography

Study Details

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.

Conditions

Breast Neoplasms

Ultrasonography

Study ID

NCT00649337

Start date

Jan, 2003

Status verified date

Mar, 2008

Completion date

Jan, 2010

Anticipated

Primary completion date

Jul, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • greater than 7 cm compressed breast thickness at mammography

Study Design

Enrollment

4650 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 1

Adjunct screening with sonocine

Interventions

Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography

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.

Primary outcome measure

  • Numbers of breast cancers detected [ Time Frame: One year after sonocine screening ]

Central Contacts and Locations

Central contacts

Kevin M Kelly, M.D.

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

Locations

Huntington Memorial Hospital/Hill Breast Center

Recruiting

Pasadena, California, United States, 91105

More Information

Sponsor

SonoCine, Inc.

Last update posted

Apr 1, 2008

Last verified

Mar, 2008

Keywords

  • mammography
  • ultrasound
  • breast cancer
  • screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SonoCine, Inc. on 2008-04-01.