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

Phase 1

Withdrawn

• Conditions: Head and Neck Carcinoma
• Interventions: Procedure: Image-Guided Surgery; Drug: Indocyanine Green Drug

• Registration Number: NCT03745690
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Study Start: 2018-12-12
• Primary Completion: 2021-06-08
• Study Completion: 2021-06-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (near-infrared image guided surgical resection)	Image-Guided Surgery	Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
Treatment (near-infrared image guided surgical resection)	Indocyanine Green Drug	Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.

Primary Outcome Measures

Name	Time	Method
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events	Up to 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Successful tumor fluorescence imaging data gathered for all patients included in the study	Up to 30 days	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.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States