Frequency Domain Optical Imaging

Study Overview
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Brief Summary
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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.

Detailed Description
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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: MR-guided NIR absorption and fluorescence imaging of the breast is feasible in the setting of a clinical breast exam MR-guided NIR absorption and fluorescence imaging of the breast provides spatial localization and contrast of a breast abnormality that is superior to NIR absorption and fluorescence tomography alone.

Official Title
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Frequency Domain Optical Imaging of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: MR-guided Near Infrared optical tomography


Participation Criteria
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Eligibility Criteria
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HEALTHY VOLUNTEERS Inclusion Criteria: Female, ≥20 years old Breast size and epithelial integrity adequate to allow NIR imaging exams. Ability to provide written informed consent No serious associated psychiatric illnesses. Exclusion Criteria: Absolute or relative contraindication to MRI: the presence of an electronic implant, such as a pacemaker the presence of a metal implant, such as an aneurysm clip claustrophobia the presence of other contraindication(s), as determined by the MRI technologists and radiologists. Pregnancy WOMEN WITH BREAST ABNORMALITIES Inclusion: Female, ≥ 20 years old. Breast size and epithelial integrity adequate to allow NIR imaging exams. Ability to provide written informed consent. No serious associated psychiatric illnesses. A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination. Exclusion: Absolute or relative contraindication to MRI: the presence of an electronic implant, such as a pacemaker the presence of a metal implant, such as an aneurysm clip claustrophobia the presence of other contraindication(s), as determined by the MRI technologists and radiologists. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MR-guided NIR<br>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. | Diagnostic Test: MR-guided Near Infrared optical tomography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |