Image Quality Assessment for Screening and Diagnostic Mammography

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine the image quality of images using a new investigational medical imaging device.

Official Title
-----------------
Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)

Conditions
-----------------
Breast Health

Intervention / Treatment
-----------------
* Device: Full Field Digital Mammography
* Device: Digital Breast Tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are women aged 40 years or older (≥40 years old); Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment; Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off; Are able to walk without assistive devices; Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and Are willing to provide written informed consent to participate. Exclusion Criteria: Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes; Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast; Are currently lactating; Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Field Digital Mammography<br>2-dimensional breast imaging | Device: Full Field Digital Mammography<br> <br> * Other names: 2D Mammography;|
| Experimental: Digital Breast Tomosynthesis<br>3-dimensional breast imaging | Device: Digital Breast Tomosynthesis<br> <br> * Other names: DBT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acceptable Overall Clinical Image Quality | Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists (readers). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012). | At enrollment completion approximately 3 months post initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. | Safety-related endpoint data (adverse events, serious adverse event, unanticipated device effect, and device defects) were monitored from all subjects for the duration of their participation. Results were summarized by cohort. | Through study completion, approximately 3 months |