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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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This purpose of this clinical study to develop and test technology associated with near infrared (NIR) optical tomography of the breast (the use of light at NIR wavelengths to image the breast) as an adjunct to mammography and breast MRI.
The purpose of this clinical study is to demonstrate the feasibility of NIR absorption and fluorescence imaging of the female breast when the method is guided by breast MRI. The hypotheses to be tested are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-guided NIR | Other | Women with breast abnormalities will undergo an "optical exam" (NIR) in combination with MRI where the NIR light imaging system illuminates the breast from multiple positions covering the area of interest. A total of 60 women will be evaluated: 20 with breast abnormalities receiving gadolinium (Gd) contrast enhancement, 20 with breast abnormalities receiving both Gd-contrast enhancement and indocyanine green (ICG) contrast enhancement, and 20 healthy volunteers not receiving any contrast agents. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-guided Near Infrared optical tomography | Diagnostic Test |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone | Women will participate in MR-guided NIR exams which include both MR and optical contrast agents. These imaging outcomes will be compared to exams where only the MR contrast agent is used as well as to exams where no contrast agents are administered. | During imaging and evaluation by a radiologist or medical technologist, up to 90 minute |
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HEALTHY VOLUNTEERS
Inclusion Criteria:
Exclusion Criteria:
Absolute or relative contraindication to MRI:
Pregnancy
WOMEN WITH BREAST ABNORMALITIES
Inclusion:
Exclusion:
Absolute or relative contraindication to MRI:
Pregnancy
A history of allergy to iodides
A GFR < 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of NIR/MR imaging.
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| Name | Affiliation | Role |
|---|---|---|
| Keith D Paulsen, PhD | Dartmouth College | Principal Investigator |
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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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This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
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| D017437 |
| Skin and Connective Tissue Diseases |