N/A
N=24
Image Quality Assessment for Screening and Diagnostic Mammography
Breast Health
Bottom Line
View on ClinicalTrials.gov: NCT02786004 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Number of Participants With Acceptable Overall Clinical Image Quality — 14; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Full Field Digital Mammography (Device); Digital Breast Tomosynthesis (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acceptable Overall Clinical Image Quality |
14; 9 | — |
| SECONDARY Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. |
0; 0; 0; 0; 0; 0 | — |
Summary
This study is being conducted to determine the image quality of images using a new investigational medical imaging device.
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).
Data sourced from ClinicalTrials.gov (NCT02786004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.