MRg-NIRS Imaging System Breast Cancer Trial

This trial is designed to determine if the MRg-NIRS system will contribute significantly to improved clinical management of women receiving breast magnetic resonance imaging (MRI) by achieving diagnostic performance comparable to or better than dynamic contrast-enhanced (DCE) breast MRI alone.

The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer. The women enrolled in the trial will be those who have a newly diagnosed breast cancer.

Inclusion criteria

• Females age ≥ 18 years old
• Participants capable of providing written informed consent
• Women with a recent diagnosis of breast cancer.
• Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
• Women who are in pre-surgical planning must have had a breast biopsy at least 10 days prior to the MRg-NIRS exam.

Exclusion criteria

• Participants with absolute or relative contraindication to MRI:

• the presence of an electronic implant, such as a pacemaker
• the presence of a metal implant, such as an aneurysm clip
• claustrophobia
• renal failure (FDA's guidance for gadolinium of a creatinine clearance less than 30 mL/1.73 m2 BSA)
• Pregnant women
• Breast implants
• Prisoners
• Participants with visually inadequate healing from breast biopsy.