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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the MRg-NIRS platform | Diagnostic performance will be measured in terms of sensitivity, specificity and area under the receiver-operator characteristic curve (ROC). | up to one hour on day of MRI |
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Inclusion Criteria:
Exclusion Criteria:
Participants with absolute or relative contraindication to MRI:
Pregnant women
Breast implants
Prisoners
Participants with visually inadequate healing from breast biopsy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith D. Paulsen, PhD | Contact | 603-646-2695 | Keith.D.Paulsen@Dartmouth.edu | |
| Shudong Jiang, PhD | Contact | Shudong.Jiang@Dartmouth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keith D. Paulsen, PhD | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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| D017437 |
| Skin and Connective Tissue Diseases |