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Completed

NCT Number: NCT01807754

Simulated Screening Study for Breast Imaging

This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:

1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)

2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

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Key information

Age range

30 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:

  • Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.
  • Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with possible masses
  • All women should have had mammograms at University of Michigan Health System within 1 year before this research study.

Exclusion criteria

  • Women who are physically unable to tolerate the length of the scan.
  • Women who are less than 30 years of age or older than 80 years of age
  • Women who are pregnant or lactating
  • Women whose mass is in an area of the breast which makes it difficult to see in the research scans
  • Womens with a single diagnosis of mammographic calcifications
  • Women who have had a breast cancer with lumpectomy
  • Women who are prisoners
  • Women who are students or staff of investigators
  • Women who cannot give consent
  • Women with mammograms classified as probably benign because of follow-up of a recent benign biopsy.
  • Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting and Data System) category 0(incomplete) on their most recent mammograms.
  • Males, because their breast tissue is not easily imaged and numbers of potential cases are too few.

Treatment and study plan

X-ray and ultrasound imaging scanning

Procedure

Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging.

Other names: Digital tomosynthesis mammogram and automated ultrasound

Photoacoustic imaging scans for breast cancer screening

Procedure

The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast.

Other names: Optoacoustic Imaging

Primary outcomes

  1. Evaluation of new breast imaging devices

    Time frame: 3 years

    To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.

Secondary outcomes

  1. Determining the ratio of "patient call backs"

    Time frame: 5 years

    To determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2013
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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