Breast Health
Conditions
Brief summary
This study is being conducted to determine the image quality of images using a new investigational medical imaging device.
Interventions
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Field Digital Mammography 2-dimensional breast imaging
Full Field Digital Mammography | 14 |
| Digital Breast Tomosynthesis 3-dimensional breast imaging
Digital Breast Tomosynthesis | 9 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Full Field Digital Mammography | Digital Breast Tomosynthesis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 9 Participants | 23 Participants |
| Region of Enrollment United States | 14 participants | 9 participants | 23 participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 10 |
| other Total, other adverse events | 0 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 14 | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Field Digital Mammography | Number of Participants With Acceptable Overall Clinical Image Quality | 14 Participants |
| Digital Breast Tomosynthesis | Number of Participants With Acceptable Overall Clinical Image Quality | 9 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Field Digital Mammography | 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 |
| Full Field Digital Mammography | 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 |
| Full Field Digital Mammography | 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 |
| Full Field Digital Mammography | 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 |
| Digital Breast Tomosynthesis | 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 |
| 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 |
| Digital Breast Tomosynthesis | 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 |
| Digital Breast Tomosynthesis | 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 |