Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer

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