A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts

Exclusion Criteria

• •1. Male by birth.
• •2. Individual is less than 40 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 RI8 scan.
• •6. Subjects who are pre-menopausal and are between the 14th and 28th day after the start of the menstrual cycle
• •7. Subjects who have significant existing breast trauma.
• •8. Subjects who have undergone lumpectomy/mastectomy.
• •9. Subjects who have undergone breast reduction or breast augmentation.
• •10. Subjects who have undergone any other type of breast surgery, including surgical biopsy.
• •11. Subjects who have large breast scar / breast deformation
• •12. Subjects who have undergone a breast needle biopsy within the 6-week period prior to their intended enrollment into the study.
• •13. Subjects who have a temperature \> 100° F (37.8C) degrees on the day of the RI8 imaging.
• •14. Subjects who are pregnant or lactating.
• •15. Subjects with known Raynaud's Disease.
• •16. Subjects with known Mastitis.
• •17. Subjects diagnosed with epileptic seizures.
• •18. Subjects with weight \> 135kg (\~300 Lbs.).
• •19. Subjects who are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session.
• •20. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
• •21. Subject with kidney failure
• •22. Subject with known allergy to gadolinium
• •23. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
• •24. Inmates (45 CFR 46.306) or mentally disabled individuals.
• •25. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
• •26. Subjects currently participating in another investigational clinical study.
• •27. Subject scheduled for a biopsy due to suspicious symptomatic lump
• •28. Subjects who participated in the Validation Phase will not be able to participate in the Testing Phase