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


N/A
18 Years
N/A
Open (Enrolling)
Both
Surgical Resection of Tumor for Patients Whose Cancer Will be Treated Surgically

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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 InstituteAtlanta, Georgia  30322