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CompletedNCT02786004Updated Nov 7, 2018Results posted

Image Quality Assessment for Screening and Diagnostic Mammography

An interventional study of Full Field Digital Mammography and Digital Breast Tomosynthesis in Breast Health, sponsored by GE Healthcare. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by GE Healthcare · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Breast Health
03

In context

Lead sponsor

GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Full Field Digital Mammography

    2-dimensional breast imaging

    Device: Full Field Digital Mammography

  • Experimental
    Digital Breast Tomosynthesis

    3-dimensional breast imaging

    Device: Digital Breast Tomosynthesis

Interventions

  • DeviceFull Field Digital Mammography

    Also known as: 2D Mammography

  • DeviceDigital Breast Tomosynthesis

    Also known as: DBT

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At enrollment completion approximately 3 months post initiation

Secondary outcomes

  1. 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.

    Time frame: Through study completion, approximately 3 months

07

Results

Posted Jul 21, 2017

Participant flow

Participant flow — Overall Study
MilestoneFull Field Digital MammographyDigital Breast Tomosynthesis
Started1410
Completed149
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryNumber 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).

Time frame:
At enrollment completion approximately 3 months post initiation
Reported as:
Count of participants · Participants
Number of Participants With Acceptable Overall Clinical Image Quality
ParticipantsFull Field Digital MammographyDigital Breast Tomosynthesis
Number of Participants With Acceptable Overall Clinical Image Quality149
SecondaryNumber 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.

Time frame:
Through study completion, approximately 3 months
Reported as:
Number · participants
Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.
participantsFull Field Digital MammographyDigital Breast Tomosynthesis
Adverse Events00
Serious Adverse Events00
Unanticipated Device Effect00
Device Defects11

Adverse events

Collected over Adverse events were monitored for the duration of subject participation in the study, which was approximately 2 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Full Field Digital Mammography0/14 (0%)0/14 (0%)0/14 (0%)
Digital Breast Tomosynthesis0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Full Field Digital MammographyDigital Breast TomosynthesisTotal
<=18 years000
Between 18 and 65 years14923
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Full Field Digital MammographyDigital Breast TomosynthesisTotal
Female14923
Male000
Region of Enrollment
Region of Enrollment(participants)Full Field Digital MammographyDigital Breast TomosynthesisTotal
United States14923
08

Study locations

1 site
  • Carolina Breast Imaging Specialist
    Greenville, North Carolina 27834, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02786004
Lead sponsor
GE Healthcare
Responsible party
Sponsor
First posted
May 30, 2016
Start date
Feb 2016
Primary completion
May 2016
Completion
May 2016
Results posted
Jul 21, 2017
Last update
Nov 7, 2018

Study contacts

Bruce Schroeder, MD
principal investigator · Carolina Breast Imaging Specialists

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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