Simulated Screening Study for Breast Imaging

NCT01807754 | Completed DMC

• 2 other identifiers: HUM 000692942R01CA091713
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cysts; Breast Tumors

Keywords

automated ultrasound imaging (AUS); digital breast tomosynthesis (DBT); photoacoustic imaging (PAT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determining the ratio of "patient call backs"

  5 years

Study Arms (1)

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; Procedure: Photoacoustic imaging scans for breast cancer screening

Interventions

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.

Also known as: Digital tomosynthesis mammogram and automated ultrasound

Imaging scans for breast cancer screening

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.

Also known as: Optoacoustic Imaging

Imaging scans for breast cancer screening

Eligibility Criteria

• Age: 30 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Cyst; Breast Neoplasms

Interventions

X-Rays; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Ultrasonic Waves; Sound; Radiation, Nonionizing

Study Officials

• Paul L Carson, PhD

  Univ. of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: March 8, 2013
• Study Start: December 1, 2012
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)