Clinical trial · Interventional
Phase II Panitumumab-IRDye800 in Head & Neck Cancer
Phase II Open-Label Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures
NCT04511078CI-TRIAL-00099635recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panitumumab-IRDye800 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panitumumab-IRDye800
- description
- 50 mg infusion of panitumumab-IRDye800 given over 60 minutes
- interventionNames
- Drug: Panitumumab-IRDye800
Primary outcomes (1)
- measure
- Tumor to background ratio of fluorescence (TBR)
- timeFrame
- Day 0 through Day 15
- description
- fluorescence intensity of tumor tissue compared to that of normal surrounding tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck 2. Diagnosis of 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. 3. Planned standard of care surgery with curative intent for squamous cell carcinoma 4. Male or female patients age ≥ 18 years 5. Have life expectancy of more than 12 weeks 6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1 7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin ≥ 9 gm/dL 2. Absolute Neutrophil Count ≥ 1500 3. White Blood Cell count \> 3000/mm3 4. Platelet count ≥ 100,000/mm3 5. Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: 1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800 2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF 3. History of infusion reactions to any monoclonal antibody therapies 4. Women who are pregnant or breast-feeding 5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) 6. Magnesium or potassium lower than the normal institutional values 7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents 8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis 9. TSH \> 13 micro International Units/mL
References
Publications (0)
Data not yet available
No reference posted for this study.