NCT01884584

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Indocyanine green (ICG)	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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-06-24
• Last updated: 2017-03-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study