Simulated Screening Study for Breast Imaging

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

Study Overview

• Status: Completed
• Conditions: Breast Tumors; Breast Cysts
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: 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 Names: Optoacoustic Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of new breast imaging devices	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining the ratio of "patient call backs"	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.	5 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Paul L Carson, PhD, Univ. of Michigan

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 23, 2020
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: automated ultrasound imaging (AUS); digital breast tomosynthesis (DBT); photoacoustic imaging (PAT)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Cysts; Breast Diseases; Breast Neoplasms; Breast Cyst
• Other Study ID Numbers: HUM 00069294; 2R01CA091713 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO