Overview

This trial is active, not recruiting.

Condition malignant neoplasm
Treatment indocyanine green (icg)
Phase phase 1
Sponsor Emory University
Start date June 2012
End date April 2017
Trial size 50 participants
Trial identifier NCT01884584, IRB00053609, RAD2162-11

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
indocyanine green (icg) Cardiogreen
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
Principal investigator David Kooby, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Emory University.