Routine Screening Mammography
Conditions
Keywords
Screening Mammogram, Mammogram, Digital Breast Tomosynthesis (DBT)
Brief summary
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
Detailed description
This study is designed to acquire Fujifilm DBT HR mode images and following image acquisition, includes a Clinical Image Evaluation study to assess whether Fujifilm HR DBT images are of sufficiently acceptable quality for use in clinical mammography.
Interventions
DEVICEDBT HR mode image acquisition
Fujifilm DBT HR image acquisition.
Sponsors
Fujifilm Medical Systems USA, Inc.
International HealthCare, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Asymptomatic women who received a final BI-RADS Assessment Category of 1 or 2 on their routine screening mammogram will be invited and consented to have images obtained using DBT HR mode, with either N-mode or H-mode dose. These images will then be reviewed by expert radiologists where they will judge if the images are of sufficiently acceptable overall clinical image quality for use in clinical mammography.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol; * Have the ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling; * Be female; * Be at least 40 years of age; * Be asymptomatic; and * Have received a final BI-RADS Assessment Category of 1 or 2 (negative or benign findings) on her routine screening mammogram.
Exclusion criteria
* Has a breast implant; * Is pregnant or believes she may be pregnant; * Has delivered and expressed the intention to breast-feed or is currently breast-feeding; * Has significant existing breast trauma with the last one (1) year; * Has any breast symptoms (e.g., breast lump, pain, nipple discharge); * Has been diagnosed or treated for breast cancer within the last year; or * Is an inmate (see US Code of Federal Regulations 45 CFR 46.306).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Acquisition | Each study participant will attend a single study visit (acquisition). | To acquire appropriate and sufficient cases to support the Clinical Image Evaluation part of the study. |
| Clinical Image Evaluation - Image quality | Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day. | To determine if the DBT HR mode clinical images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable overall clinical image quality for use in clinical mammography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Image Acquisition - Safety evaluation | Each study participant will attend a single study visit (acquisition). | To further evaluate the safety of DBT HR mode imaging by analyzing frequency and characteristics of any adverse events. |
| Clinical Image Evaluation - Pass rating | Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day. | To determine whether overall clinical image quality is acceptable, as assessed by expert mammographic radiologists. Study success requires all of the cases to receive a Pass rating. |
Contacts
CONTACTNicole M. Calabrese, MS
PRINCIPAL_INVESTIGATORLaurie L. Fajardo, MD
University of Utah
Outcome results
None listed