Trial Outcomes & Findings for Image Quality Assessment for Screening and Diagnostic Mammography (NCT NCT02786004)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

At enrollment completion approximately 3 months post initiation

Results posted on

2018-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Full Field Digital Mammography 2-dimensional breast imaging Full Field Digital Mammography	Digital Breast Tomosynthesis 3-dimensional breast imaging Digital Breast Tomosynthesis
Overall Study STARTED	14	10
Overall Study COMPLETED	14	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Full Field Digital Mammography 2-dimensional breast imaging Full Field Digital Mammography	Digital Breast Tomosynthesis 3-dimensional breast imaging Digital Breast Tomosynthesis
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Image Quality Assessment for Screening and Diagnostic Mammography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Field Digital Mammography n=14 Participants 2-dimensional breast imaging Full Field Digital Mammography	Digital Breast Tomosynthesis n=9 Participants 3-dimensional breast imaging Digital Breast Tomosynthesis	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	9 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Full Field Digital Mammography n=14 Participants 2-dimensional breast imaging Full Field Digital Mammography	Digital Breast Tomosynthesis n=9 Participants 3-dimensional breast imaging Digital Breast Tomosynthesis
Number of Participants With Acceptable Overall Clinical Image Quality	14 Participants	9 Participants

SECONDARY outcome

Timeframe: Through study completion, approximately 3 months

Population: Twenty-four subjects were enrolled into the study, of which 14 were enrolled into the FFDM cohort and 10 into the DBT cohort. One (1) subject was withdrawn from the DBT cohort but was followed for AE, SAE, and UADE for the duration of her participation.

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.

Outcome measures

Outcome measures
Measure	Full Field Digital Mammography n=14 Participants 2-dimensional breast imaging Full Field Digital Mammography	Digital Breast Tomosynthesis n=10 Participants 3-dimensional breast imaging Digital Breast Tomosynthesis
Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. Adverse Events	0 participants	0 participants
Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. Serious Adverse Events	0 participants	0 participants
Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. Unanticipated Device Effect	0 participants	0 participants
Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. Device Defects	1 participants	1 participants

Adverse Events

Full Field Digital Mammography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Digital Breast Tomosynthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Heckel

GE Healthcare

Phone: 262-312-7269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place