Clinical trial · Interventional
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-Guided Surgery | Procedure | — | UNRESOLVED |
| Indocyanine Green Drug | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (near-infrared image guided surgical resection)
- description
- Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
- interventionNames
- Procedure: Image-Guided Surgery
- Drug: Indocyanine Green Drug
Primary outcomes (1)
- measure
- Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
- timeFrame
- Up to 30 days
- 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.
Secondary outcomes (1)
- measure
- Successful tumor fluorescence imaging data gathered for all patients included in the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available