Simulated Screening Study for Breast Imaging

Breast Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807754
• Other study ID #: HUM 00069294
• Secondary ID: 2R01CA091713
• Status: Completed
• Start date: December 2012
• Est. completion date: April 23, 2020

Study information

• Verified date: May 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cyst
• Breast Cysts
• Breast Neoplasms
• Breast Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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