Recruiting

MRg-NIRS Imaging

Sponsor:

Keith D. Paulsen

Code:

NCT06400563

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MRg-NIRS

Study Details

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

Study ID

NCT06400563

Start date

Nov 25, 2024

Status verified date

Jan, 2026

Completion date

Jul 1, 2034

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

other: MR-guided 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.

Interventions

MRg-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.

Primary outcome measure

  • Optical sensitivity of the MRg-NIRS platform [ Time Frame: up to one hour on day of MRI ]

Central Contacts and Locations

Central contacts

Keith D. Paulsen, PhD

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

Shudong Jiang, PhD

Shudong.Jiang@Dartmouth.edu

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Keith D Paulsen, PhD

Keith.D.Paulsen@Dartmouth.edu

Principal Investigator:

Keith D Paulsen, PhD

More Information

Sponsor

Keith D. Paulsen

Last update posted

Jun 23, 2026

Last verified

Jan, 2026

Keywords

  • MRI
  • MRg-NIRS
  • Near-infrared Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Keith D. Paulsen on 2026-06-23.