MRg-NIRS Imaging System Breast Cancer Trial

Summary

This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).

Eligibility

Inclusion Criteria:

1. Females age ≥ 18 years old
2. Participants capable of providing written informed consent
3. Women with a recent diagnosis of breast cancer.
4. Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
5. 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:

1. Participants with absolute or relative contraindication to MRI:

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

Conditions2

Locations1 site

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