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Simulated Screening Study for Breast Imaging

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ClinicalTrials.gov Identifier: NCT01807754
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : May 21, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan

Brief 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.


Condition or disease Intervention/treatment
Breast Cysts Breast Tumors Procedure: X-ray and ultrasound imaging scanning Procedure: Photoacoustic imaging scans for breast cancer screening

Detailed Description:

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

1) 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.

2. 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.

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
Study Start Date : December 2012
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Imaging scans for breast cancer screening

To simulate the performance of the combination of three new breast imaging systems to digital mammography and hand-held ultrasound that are currently used to find and evaluate breast masses.

These three different systems make images of the breast in several ways to find breast masses and to distinguish normal and abnormal masses. This may result in less unnecessary call-backs from mammography.

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.
Other Name: Digital tomosynthesis mammogram and automated ultrasound

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.
Other Name: Optoacoustic Imaging




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes women who have had a mammogram at University of Michigan within one year who have been referred to the study. Participants may have a breast mass, either benign or cancerous.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807754


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Paul L Carson, PhD Univ. of Michigan
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Responsible Party: Paul L. Carson Ph.D, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01807754    
Other Study ID Numbers: HUM 00069294
2R01CA091713 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paul L. Carson Ph.D, University of Michigan:
automated ultrasound imaging (AUS)
digital breast tomosynthesis (DBT)
photoacoustic imaging (PAT)
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Cyst
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cysts