The purpose of the study is to assess the effectiveness of MIRA in classifying women with
dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for
correctly classifying women with breast cancer and to evaluate the safety of the device.
In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle
biopsy due to lesions detected by other imaging modalities.
- Women who are between 30 to 70 years of age and who are asymptomatic and scheduled to
undergo routine breast cancer screening (MRI and/or mammography) OR
- Women who are between 30 to 79 years of age and scheduled for image-guided needle
biopsy as a result of findings obtained during standard of care imaging modalities
(mammography, ultrasound and/or MRI) performed at the clinical site that participates
in the study.
Exclusion Criteria:
1. Contraindication to bilateral mammography or MRI.
2. Subjects who are unable to read, understand and execute the informed consent
procedure.
3. Subjects who have had mammography, ultrasound or MRI examination performed on the day
of the study prior to MIRA scan.
4. Subjects who have significant existing breast trauma.
5. Subjects who have undergone lumpectomy/mastectomy.
6. Subjects who have undergone breast reduction or breast augmentation.
7. Subjects who have undergone any other type of breast surgery.
8. Subjects who have large breast scar / Breast deformation.
9. Subjects who have undergone a breast needle biopsy within the 6-month period prior to
their intended enrollment into the study.
10. Subjects who have a temperature > 37.8C degrees on the day of the MIRA imaging.
11. Subjects who are pregnant or lactating.
12. Subjects who have had placement of an internal breast marker.
13. Subjects with known Raynaud's Disease.
14. Subjects that are claustrophobic or have physical limitations that do not allow them
to sit in the system chair for the required imaging session.
15. Subjects with implanted pacemaker/defibrillator, implanted venous access device
(portacath) or other implanted devices.
16. Inmates or mentally disabled individuals.
17. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the
purpose of planning cancer therapy).
18. Subjects who participated in the Calibration Phase will not be able to participate in
the Testing Phase.
19. Subjects currently participating in another investigational clinical study.
20. Subjects undergoing breast MR for pre-staging.
1. determining MIRA's PPV (positive predictive value) (Time Frame - 24 months): The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using positive MRI (MRI BI-RADS >= 3) as a reference test in cohort of women with negative (Mammography BI-RADS 1 or 2).
The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using the histological diagnosis as the reference test in ALL women participated in the study.
