Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | April 2018 |
Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
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.
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.
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.
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.
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.
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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