Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
18 Years
N/A
Both
Surgical Resection of Tumor for Patients Whose Cancer Will be Treated Surgically
Trial Information
Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
Inclusion Criteria:
(1) Patients with a tumor that will be treated surgically
Exclusion Criteria:
1. Patients with a known history of reaction to iodine or iodine-containing compounds.
2. Pregnant women. Any patients found to be pregnant will be excluded from the study.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome 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)
Outcome Description:
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).
Outcome Time Frame:
1-2 weeks
Safety Issue:
No
Principal Investigator
James Provenzale, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Emory University-Winship Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
RAD2162-11
NCT ID:
NCT01884584
Start Date:
June 2012
Completion Date:
Related Keywords:
- Surgical Resection of Tumor for Patients Whose Cancer Will be Treated Surgically
Name | Location |
|---|---|
| Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |
