Breast Cancer Clinical Trial

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).

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Full 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.

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Eligibility Criteria

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 1.5 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
Personal history of breast cancer in the ipsilateral breast.
Prisoners
Participants with visually inadequate healing from breast biopsy.

Study is for people with:

Breast Cancer

Estimated Enrollment:

20

Study ID:

NCT06400563

Recruitment Status:

Not yet recruiting

Sponsor:

Keith D. Paulsen

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There is 1 Location for this study

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Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

20

Study ID:

NCT06400563

Recruitment Status:

Not yet recruiting

Sponsor:


Keith D. Paulsen

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