Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Real Imaging Ltd.
Age
30–70
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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)
You may not be if
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
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