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

NCT03745690 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 18-000168NCI-2018-02094
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Successful tumor fluorescence imaging data gathered for all patients included in the study

  Up to 30 days

Study Arms (1)

Treatment (near-infrared image guided surgical resection)

EXPERIMENTAL

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

Procedure: Image-Guided Surgery; Drug: Indocyanine Green Drug

Interventions

Image-Guided Surgery PROCEDURE

Undergo near-infrared image guided surgical resection

Treatment (near-infrared image guided surgical resection)

Indocyanine Green Drug DRUG

Given IV

Also known as: IC-GREEN, ICG Drug in solution

Treatment (near-infrared image guided surgical resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Surgery, Computer-Assisted; Indocyanine Green; Solutions

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Preparations

Study Officials

• Abie Mendelsohn

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: December 12, 2018
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

US (1)