Breast Cancer Stage
Conditions
Brief summary
This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).
Detailed description
1. Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe. 2. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))
Interventions
DEVICEImagio
Imagio - both ultrasound probe and Duplex OA probe
Sponsors
American College of Radiology
Seno Medical Instruments Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a signed and dated informed consent, prior to initiation of any study-related activities. 2. Is at least 18 years of age. 3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging. 4. Is willing and able to comply with protocol-required scans
Exclusion criteria
1. Is pregnant or lactating. 2. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view. 3. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline. 4. Is currently undergoing phototherapy. 5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity. 6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal. 7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months. 8. Currently has mastitis. 9. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Imagio Image Sets Collected | Baseline | Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled. |
| Number of Subjects With Completed Pathology Results | Baseline | Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imagio Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes
Imagio: Imagio - both ultrasound probe and Duplex OA probe | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Imagio |
|---|---|
| Age, Continuous | 44.3 Years STANDARD_DEVIATION 15.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 1 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Number of Participants With Imagio Image Sets Collected
Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imagio | Number of Participants With Imagio Image Sets Collected | 38 Participants |
Primary
Number of Subjects With Completed Pathology Results
Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imagio | Number of Subjects With Completed Pathology Results | 23 Participants |