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

Jonsson Comprehensive Cancer Center

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Head and Neck Carcinoma

Treatments

Drug: Indocyanine Green Drug

Procedure: Image-Guided Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03745690

NCI-2018-02094 (Registry Identifier)

18-000168 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.