Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
The objective of the study is to estimate the diagnostic accuracy of cancer detection when
 MIRA technology is combined with mammography, by evaluating the area under the ROC curve
 (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader
 Study on a subset of women with histology confirmed cancer and healthy women with dense
 breast.
Inclusion Criteria:

 A. Subjects who are asymptomatic and scheduled to undergo routine screening mammography

 OR

 B. Subjects scheduled for image guided needle biopsy as a result of findings obtained
 during standard of care imaging modalities

 AND

 C. Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously
 dense breast tissue (Density C or D)

 Exclusion Criteria:

 1. Male by birth.

 2. Individual is less than 30 and greater than 70 years old.

 3. Contraindication to bilateral mammography or MRI

 4. Subjects who are unable to read, understand and execute the informed consent
 procedure.

 5. Subjects who have had mammography ultrasound or MRI examination performed on the day
 of the study prior to MIRA scan.

 6. Subjects who have significant existing breast trauma.

 7. Subjects who have undergone lumpectomy/mastectomy.

 8. Subjects who have undergone breast reduction or breast augmentation.

 9. Subjects who have undergone any other type of breast surgery, excluding surgical
 biopsy.

 10. Subjects who have large breast scar / Breast deformation

 11. Subjects who have undergone a breast needle biopsy or a surgical biopsy within the 6
 month period prior to their intended enrollment into the study.

 12. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA
 imaging

 13. Subjects who are pregnant or lactating

 14. Subjects with known Raynaud's Disease

 15. Subjects that are claustrophobic or have physical limitations that do allow them to
 sit in the system chair for the required imaging session.

 16. Subjects with implanted pacemaker/defibrillator, implanted venous access device
 (portacath) or other implanted devices

 17. Subject with kidney failure

 18. Subject with known allergy to gadolinium

 19. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the
 past two year)

 20. Inmates (45 CFR 46.306) or mentally disabled individuals

 21. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the
 purpose of planning cancer therapy)

 22. Subjects currently participating in another investigational clinical study

 23. Subjects who participated in the Calibration Phase will not be able to participate in
 the Testing Phase