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NCT06400563NARecruiting

MRg-NIRS Imaging System Breast Cancer Trial

Keith D. Paulsen

Start Date

11/25/2024

Completion Date

7/1/2034

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).

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 83 years

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.

Interventions

DEVICE

MRg-NIRS

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Conditions

Breast Cancer

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States