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

GE Healthcare1 site in 1 country24 target enrollmentFebruary 2016

ConditionsBreast Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Health
Sponsor: GE Healthcare
Enrollment: 24
Locations: 1
Primary Endpoint: Number of Participants With Acceptable Overall Clinical Image Quality
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to determine the image quality of images using a new investigational medical imaging device.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

May 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Number of Participants With Acceptable Overall Clinical Image Quality

Time Frame: At enrollment completion approximately 3 months post initiation

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).

Secondary Outcomes

Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.(Through study completion, approximately 3 months)