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

Emory University

Status and phase: Completed; Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: Indocyanine green (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01884584

RAD2162-11 (Other Identifier)

IRB00053609

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Indocyanine green (ICG)

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine green (ICG)