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

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine Green (ICG)

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.

Other names: Cardiogreen

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jun 24, 2013
Registry last updated: Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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