MRg-NIRS Imaging System Breast Cancer Trial

Keith D. Paulsen

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: MRg-NIRS

Study type: Interventional

Funder types: Other

Identifiers

NCT06400563

STUDY02001582

Details and patient eligibility

About

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).

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 83 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MR-guided NIRS

Other group

Description:

The MRg-NIRS device will be tested to see if it accommodates different breast sizes, covers the breast fully, includes the axilla, is compatible with commercial breast MRI coil and/or biopsy systems, and the signal-to-noise ratio is high enough for MRg-NIRS image reconstruction. The study team will collect MRI-derived ROI data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will also collect diffuse optical signals at 48x48 detector source positions over one side of breast at 6 wavelengths.

Treatment:

Device: MRg-NIRS