Acquisition of Breast Mammography Images

NCT02156258 | Completed Results

• 1 other identifier: FMSU2013-004A
• Study Type: observational
• Target: 1,232
• Locations: 1 country
• Sites: 5

Brief Summary

This is a case collection study of breast images using standard and new mammography technology.

Conditions

Breast Cancer

Keywords

Imaging; Mammography

Outcome Measures

Primary Outcomes (1)

• Number of Participants for Whom Study Image Data Were Collected

  This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain.

  20 Months

Study Arms (3)

Diagnostic Cases

Collection of cases that were scheduled for biopsy (BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography

Device: FFDM Mammography; Device: DBT Mammography

Recall Cases

Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography

Device: FFDM Mammography; Device: DBT Mammography

Screening Cases

Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography

Device: FFDM Mammography; Device: DBT Mammography

Interventions

FFDM Mammography DEVICE

Standard mammography image collection

Diagnostic Cases; Recall Cases; Screening Cases

DBT Mammography DEVICE

Collection of breast images using DBT mammography

Diagnostic Cases; Recall Cases; Screening Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated

You may qualify if:

• For Screening Subjects
• Be at least 40 years of age, are
• Asymptomatic,
• Scheduled for a routine screening mammogram
• For Recall Subjects
• Be at least 18 years of age,
• Received a BIRADS 0 within the last 60 days
• Are recalled for additional imaging
• For Diagnostic Subjects
• Be at least 18 years of age,
• Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.
• Understand requirements and willing to participate in study

You may not qualify if:

• Presence of a breast implant.
• Women with only a single breast; for example, post mastectomy patients.
• Is pregnant or believes she may be pregnant.
• A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
• A woman who has significant existing breast trauma within the last one year.
• Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.
• A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.
• Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.
• Is an inmate (see US Code of Federal Regulations 45CFR46.306).

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (5)

Scottsdale Medical Imaging, Ltd

Scottsdale, Arizona, 85258, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Elizabeth Wende Breast Care, LLC

Rochester, New York, 14620, United States

Location

University of North Carolina - at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Randy Vader
• Organization: Fujifilm Medical Systems USA, Inc.

randy.vader@fujifilm.com

360-356-6821

Study Officials

• Etta D Pissano, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: May 20, 2020
• Results First Posted: May 20, 2020

Record last verified: 2020-05

Locations

US (5)