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

• ClinicalTrials.gov Identifier: NCT01884584
• Recruitment Status: Completed
• First Posted: June 24, 2013
• Last Update Posted: March 9, 2017
• Sponsor: Emory University
• Information provided by (Responsible Party): David A Kooby, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malignant Neoplasm	Drug: Indocyanine green (ICG)	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
• Study Start Date: June 2012
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: Cardiogreen

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: 1-2 weeks ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Georgia

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Emory University Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Sponsors and Collaborators

Emory University

Investigators

• Principal Investigator: David Kooby, MD; Emory University-Winship Cancer Institute

More Information

• Responsible Party: David A Kooby, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01884584
• Other Study ID Numbers: IRB00053609; RAD2162-11 ( Other Identifier: Other )
• First Posted: June 24, 2013
• Last Update Posted: March 9, 2017
• Last Verified: March 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms