Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 83
Healthy Volunteers: f
View:
• 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.
Locations
United States
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Keith D. Paulsen, PhD
Keith.D.Paulsen@Dartmouth.edu
603-646-2695
Backup
Shudong Jiang, PhD
Shudong.Jiang@Dartmouth.edu
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Keith D. Paulsen
Collaborators: Dartmouth College