MRg-NIRS Imaging System Breast Cancer Trial

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Device: MRg-NIRS

• Registration Number: NCT06400563
• Lead Sponsor: Keith D. Paulsen

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-06
• Study Start: 2024-09-23
• Status Verified: 2024-10
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-guided NIRS	MRg-NIRS	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.

Primary Outcome Measures

Name	Time	Method
Optical sensitivity of the MRg-NIRS platform	up to one hour on day of MRI	Optical data sensitivity will be measured (The sensitivity of the measurements to a given region identified by MRI, Sr, will be calculated as the sum of the log of the Jacobian times vector r. Here, r is a logical vector that identifies points within the region of interest and J is the Jacobian, the rate of change of measurements to a change in optical properties at a location in the region identified).

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of the MRg-NIRS platform	up to one hour on day of MRI	Diagnostic performance will be measured in terms of sensitivity, specificity and area under the receiver-operator characteristic curve (ROC).

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States