Back to resultsNear-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
Primary Purpose
Head and Neck Carcinoma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Image-Guided Surgery
Indocyanine Green Drug
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Carcinoma
Eligibility Criteria
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.
Sites / Locations
- UCLA / Jonsson Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (near-infrared image guided surgical resection)
Arm Description
Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03745690
First Posted
November 15, 2018
Last Updated
March 2, 2022
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03745690
Brief Title
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
June 8, 2021 (Anticipated)
Study Completion Date
June 8, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (near-infrared image guided surgical resection)
Arm Type
Experimental
Arm Description
Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
Intervention Type
Procedure
Intervention Name(s)
Image-Guided Surgery
Intervention Description
Undergo near-infrared image guided surgical resection
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green Drug
Other Intervention Name(s)
IC-GREEN, ICG Drug in solution
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
Description
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.
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Successful tumor fluorescence imaging data gathered for all patients included in the study
Description
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.
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abie Mendelsohn
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
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