Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Study Overview
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Brief Summary
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This study investigates whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.

Detailed Description
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This proposal will investigate the performance of a combined optical-MRI imaging system in diagnosis of breast cancer. A diffuse optical tomography (DOT) imaging system will be integrated with a 3.0 T MRI scanner. It is hypothesized that the additional information measured by the combined MRI/DOT system will improve the specificity of DCE-MRI (dynamic contrast enhanced MRI) in diagnosis of breast cancer. High resolution anatomic MRI and DCE-MRI has evolved into a standard clinical tool for detection and diagnosis of breast lesions. Due to its high sensitivity MRI is fast becoming the most popular imaging modality for screening young women who are susceptible to early development of breast cancer. Pre-operative MRI has also become a common procedure for detecting multifocal or multicentric diseases to facilitate surgical planning. However, despite its high sensitivity, MRI also detects many benign lesions. The low specificity may lead to a great anxiety to patients, and many unnecessary biopsies or over-treatment. Other adjunct imaging modality to improve specificity is greatly needed. MR spectroscopy (MRS) and DOT are two techniques that have great potential to provide complementary information. After the study is completed, we will be able to test the hypothesis that additional information provided by MRS and optical imaging can be used in conjunction with morphological and kinetics parameters measured by DCE-MRI to improve diagnostic accuracy of breast cancer. Furthermore, we will be able to determine among these additionally collected information, which parameter(s) are the most essential in improving diagnostic accuracy. Although the current breast imaging modalities have achieved a high success, further improvements for the subpopulation in whom conventional imaging does not work well are in great need. Our goal is to develop an imaging technology with optimized acquisition protocol to improve diagnosis of breast cancer, particularly for young women with dense breasts who need a breast MRI examination, so that they would not be subjected to false positive findings.

Official Title
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Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Disease Group
* Device: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A female older than 21 years of age, Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer. Exclusion Criteria: Pregnant, Unwilling to give informed consent, Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants, Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities, Have received orthodontic work involving ferromagnetic materials, Claustrophobic, Have had allergic response to contrast agents (such as iodine or gadolinium) previously, Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease Group<br>Patients with suspicious breast diseases | Device: Disease Group<br>* Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)<br>|
| Experimental: Control Group<br>Healthy volunteers for system testing | Device: Control Group<br>* Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions | ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT | After we meet the enrollment target |