MRg-NIRS Imaging System Breast Cancer Trial

NCT06400563 | Recruiting DMC FDA Device

• 1 other identifier: STUDY02001582
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

MRI; MRg-NIRS; Near-infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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).

  up to one hour on day of MRI

Secondary Outcomes (1)

• Diagnostic performance of the MRg-NIRS platform

  up to one hour on day of MRI

Study Arms (1)

MR-guided NIRS

OTHER

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.

Device: MRg-NIRS

Interventions

MRg-NIRS DEVICE

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.

Also known as: MR-guided NIRS Data Collection

MR-guided NIRS

Eligibility Criteria

• Age: 18 Years - 83 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.0 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.

You may not qualify if:

• 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
• Prisoners
• Participants with visually inadequate healing from breast biopsy.

Sponsors & Collaborators

• Keith D. Paulsen: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Keith D. Paulsen, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith D. Paulsen, PhD

CONTACT

603-646-2695; Keith.D.Paulsen@Dartmouth.edu

Shudong Jiang, PhD

CONTACT

Shudong.Jiang@Dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Engineering

Model Details: The study team will collect MRI-derived region of interest (ROI) data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will test whether the breast interface can provide optical measurements with positional data sensitivity \>1%. The study team will conduct two interim analyses of optical sensitivity after completion of 5-10 patient exams to decide whether the breast interface should be modified. The breast interface is a non-significant risk device.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 6, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)