Breast Cancer
Conditions
Keywords
MRI, MRg-NIRS, Near-infrared Spectroscopy
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).
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.
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.
Sponsors
Keith D. Paulsen
Dartmouth College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 83 Years
Healthy 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optical sensitivity of the MRg-NIRS platform | up to one hour on day of MRI | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of the MRg-NIRS platform | up to one hour on day of MRI | Diagnostic performance will be measured in terms of sensitivity, specificity and area under the receiver-operator characteristic curve (ROC). |
Countries
United States
Contacts
CONTACTKeith D. Paulsen, PhD
CONTACTShudong Jiang, PhD
PRINCIPAL_INVESTIGATORKeith D. Paulsen, PhD
Dartmouth College
Outcome results
None listed