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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01884584
• Date of registration: 19/06/2013
• Prospective Registration: No
• Primary sponsor: Emory University
• Public title: Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
• Scientific title: Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
• Date of first enrolment: June 2012
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01884584
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David Kooby, MD
• Affiliation: Emory University-Winship Cancer Institute

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malignant Neoplasm

Intervention(s)

Drug: Indocyanine green (ICG)

Primary Outcome(s)

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]

Secondary ID(s)

IRB00053609

RAD2162-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors