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

• Status: Suspended
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

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.