Simulated Screening Study for Breast Imaging

Completed

• Conditions: Breast Cysts; Breast Tumors
• Interventions: Procedure: X-ray and ultrasound imaging scanning; Procedure: Photoacoustic imaging scans for breast cancer screening

• Registration Number: NCT01807754
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imaging scans for breast cancer screening	Photoacoustic 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.
Imaging scans for breast cancer screening	X-ray and ultrasound imaging scanning	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of new breast imaging devices	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

Name	Time	Method
Determining the ratio of "patient call backs"	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States