Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments ffdm mammography, dbt mammography
Phase phase 3
Sponsor Fujifilm Medical Systems USA, Inc.
Start date June 2014
End date January 2016
Trial size 1232 participants
Trial identifier NCT02156258, FMSU2013-004A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Collection of cancer cases using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography
ffdm mammography
Standard mammography image collection
dbt mammography
Collection of breast images using DBT mammography
Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography
ffdm mammography
Standard mammography image collection
dbt mammography
Collection of breast images using DBT mammography
Collection of Non-Cancer Cases using FFDM Mammography and DBT Mammography
ffdm mammography
Standard mammography image collection
dbt mammography
Collection of breast images using DBT mammography

Primary Outcomes

Measure
Case Collection of Mammography Images with Breast Cancer
time frame: 20 Months
Case Collection of Mammography Images that Required Recall with No Cancer
time frame: 20 Months
Case Collection of Mammography Images with No Cancer
time frame: 20 Months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 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 Exclusion Criteria: - 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).

Additional Information

Official title Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis
Principal investigator Etta D Pissano, MD
Description This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Fujifilm Medical Systems USA, Inc..
Location data was received from the National Cancer Institute and was last updated in February 2016.