Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer

Study Overview
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Brief Summary
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The surgeon may remove a very small amount of additional tissue compared to what would be removed if you were not enrolled in the study. This tissue may prove to contain tumor or it may contain normal tissue. The surgical cavity will be examined by a special laser pen after the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells where the ICG dye collected are still remaining and the surgeon would then remove those. After the tumor and the tissue around it are removed and sent to the laboratory, the tissue may be examined using that same laser pen to see where the cancer cells are and compare that to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is hoped that what the dye shows and what is seen with the microscope will be alike.

Detailed Description
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PRIMARY OBJECTIVES: I. To validate the use of intraoperative indocyanine green (ICG) for better definition of tumor margins therefore, minimizing the necessity of a second surgical procedure to obtain negative margins. OUTLINE: Patients receive indocyanine green solution intravenously (IV) between 2-8 hours before surgery. Fluorescence measurements are taken from all specimens removed during surgery. After completion of study, patients are followed up at 48 hours.

Official Title
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Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Drug: Indocyanine green (ICG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a tumor that will be treated surgically. Exclusion Criteria: Patients with a known history of reaction to iodine or iodine-containing compounds. Pregnant women. Any patients found to be pregnant will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine green (ICG)<br>ICG will be administered by intravenous infusion over a 20 second period in a 2-8 hour time window before the time of completion of the surgical procedure. | Drug: Indocyanine green (ICG)<br>* Initial dose of 0.22 mg/kg, which has proven successful in identifying tumor tissue in canine experiments, will be used. The dose will be based on actual body weight. This dose is approximately 40% of the standard human dose for determining cardiac output.<br>* Other names: Cardiogreen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The contrast ratio (CR, defined as the integrated fluorescence intensity measured in a known tumor area divided by the integrated fluorescence intensity of a known not tumor area) | Examine the resected tissue to determine whether ICG is sensitive to tumor detection (i.e., whether ICG accumulates in tumor) and whether ICG is specific for tumor (i.e., whether ICG accumulates in normal tissue). | 1-2 weeks |