Clinical trial NCT02156258: Acquisition of Breast Mammography Images
Official title: Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Imaging
Mammography
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 1232
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants for Whom Study Image Data Were Collected
timeFrame: 20 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Ltd
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care, LLC
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - at Chapel Hill
state: North Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Medical University of South Carolina
name: Etta D Pissano, MD
role: PRINCIPAL_INVESTIGATOR
References: