MRg-NIRS Imaging System Breast Cancer Trial

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Keith D. Paulsen
Study ID
NCT06400563
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 83 Years
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Sep 23, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Keith D Paulsen, PhD
[email protected]
Roberta diFlorio-Alexander, MD (SUB_INVESTIGATOR)
Shudong Jiang, PhD (SUB_INVESTIGATOR)
Keith D Paulsen, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lebanon, NH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

Related Studies