Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
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|ClinicalTrials.gov Identifier: NCT01884584|
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm||Drug: Indocyanine green (ICG)||Phase 1|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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).
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
|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|
|Principal Investigator:||David Kooby, MD||Emory University-Winship Cancer Institute|