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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01884584
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
David A Kooby, Emory University

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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

Resource links provided by the National Library of Medicine


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




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).



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884584


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

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

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

Additional relevant MeSH terms:
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Neoplasms