Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

Inclusion Criteria:

• Female
• Woman has read, understood and signed the inform consent form
• Age: 20 years and older
• Women who are asymptomatic for breast cancer
• Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
• Women scheduled to undergo routine mammography and/or US or MRI screening

Exclusion Criteria:

• Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
• Women who had a lumpectomy surgery
• Women who had undergone mastectomy and/or reconstruction
• Women who have undergone any type of breast surgery throughout the 6 months preceding the study
• Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
• Women who have a fever on the day of the MIRA imaging
• Women who are pregnant
• Women who are breast-feeding
• Women who had undergone breast reduction/augmentation