Image Quality Assessment for Screening and Diagnostic Mammography

Not Applicable

Completed

• Conditions: Breast Health
• Interventions: Device: Digital Breast Tomosynthesis; Device: Full Field Digital Mammography

• Registration Number: NCT02786004
• Lead Sponsor: GE Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Results First Submitted: 2017-06-19
• Results First Submitted QC: 2017-06-19
• Results First Posted: 2017-07-21
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Are women aged 40 years or older (≥40 years old);
2. Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
3. Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
4. Are able to walk without assistive devices;
5. 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
6. Are willing to provide written informed consent to participate.

Exclusion Criteria

1. Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
2. Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
3. Are currently lactating;
4. Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
5. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Breast Tomosynthesis	Digital Breast Tomosynthesis	3-dimensional breast imaging
Full Field Digital Mammography	Full Field Digital Mammography	2-dimensional breast imaging

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acceptable Overall Clinical Image Quality	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Carolina Breast Imaging Specialist; 🇺🇸 Greenville, North Carolina, United States