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Simulated Screening Study for Breast Imaging

NCT01807754 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2020-05-21

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cysts
  • Breast Tumors

Interventions

PROCEDURE

X-ray and ultrasound imaging scanning

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.

PROCEDURE

Photoacoustic imaging scans for breast cancer screening

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Paul L Carson, PhD · Univ. of Michigan

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2020-04-23
Completion
2020-04-23

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01807754 on ClinicalTrials.gov