RecruitingInterventional

Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients

NCT ID: NCT06400563Sponsor: Keith D. PaulsenLast updated: 2025-11-24

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.

Arms & interventions

DeviceMRg-NIRS
The trial tests the investigator designed and developed Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) imaging system for breast cancer detection. The wearable NIRS imaging system uses 8 flex circuit strips, each with six photo-detectors (PDs) and six source fibers, that are ready to attach to a breast radially by using an adhesive nipple cover and breast tape.

Outcome measures

Primary

Optical sensitivity of the MRg-NIRS platform
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).
Time frame: up to one hour on day of MRI

Secondary

Diagnostic performance of the MRg-NIRS platform
Time frame: up to one hour on day of MRI

Eligibility criteria

Sex: FemaleAge: 18 Years to 83 YearsHealthy volunteers: No

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 locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Recruiting

Keith D Paulsen, PhD · Contact

Keith.D.Paulsen@Dartmouth.edu

Roberta diFlorio-Alexander, MD · Sub Investigator

Shudong Jiang, PhD · Sub Investigator

Keith D Paulsen, PhD · Principal Investigator