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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03745690
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
29.9
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Image-Guided Surgery
  • Drug: Indocyanine Green Drug
 Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.
SECONDARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 12, 2018
Anticipated Primary Completion Date :
Jun 8, 2021
Anticipated Study Completion Date :
Jun 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (near-infrared image guided surgical resection)

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

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

Drug: Indocyanine Green Drug
Given IV
Other Names:
  • IC-GREEN
  • ICG Drug in solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Abie Mendelsohn, UCLA / Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03745690
    Other Study ID Numbers:
    • 18-000168
    • NCI-2018-02094
    • 18-000168
    First Posted:
    Nov 19, 2018
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    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
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Mar 17, 2022