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

NCT ID: NCT01884584

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanine green (ICG)

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.

Group Type: EXPERIMENTAL

Indocyanine green (ICG)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cardiogreen

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

David A Kooby

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kooby, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University-Winship Cancer Institute

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

RAD2162-11

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00053609

Identifier Type: -

Identifier Source: org_study_id