Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer

Head and Neck Carcinoma Clinical Trial

Official title:

Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03745690
• Other study ID #: 18-000168
• Secondary ID: NCI-2018-0209418
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 12, 2018
• Est. completion date: June 8, 2021

Study information

• Verified date: March 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.

Description:

PRIMARY OBJECTIVES:

I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.

SECONDARY OBJECTIVES:

I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.

OUTLINE:

Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.

After completion of study treatment, patients are followed up for 14-30 days.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.

• Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.

• Planned standard of care surgery with curative intent for squamous cell carcinoma.

• Have life expectancy of more than 12 weeks.

• Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1.

• Hemoglobin >= 9 gm/dL.

• White blood cell count > 3000/mm^3.

• Platelet count >= 100,000/mm^3.

• Serum creatinine =< 1.5 mg/dL.

• Liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin) =< 1.5 times the upper reference range.

• Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.

• Agree to not have radioactive iodine uptake studies done within 1 week of indocyanine green.

Exclusion Criteria:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

• Allergy to iodine or iodinated materials.

• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Procedure:
• Image-Guided Surgery
Undergo near-infrared image guided surgical resection

Drug:
• Indocyanine Green Drug
Given IV

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events	Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.	Up to 30 days
Secondary	Successful tumor fluorescence imaging data gathered for all patients included in the study	The effect of indocyanine green will be assessed by changes in tumor-to-background ratio (TBR). Tumor to background (TBR) data will be generated from still images collected throughout the procedure as previously described (Heath, Deep et al.). The presence of fluorescence in normal surrounding tissue will be correlated with fluorescence within the tumor mass. The linear relationship between fluorescence and tumor size will be computed as Spearman?s correlation coefficient. Continuous variable means (e.g., fluorescence intensity) will be compared to histological quantification of tumor as measured by the greatest dimension identified on the histopathological assessment.	Up to 30 days