Clinical trial · Interventional
Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective) Neck Dissection for Metastatic Lymph Node Identification in Patients With Head and Neck Cancer
- 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)
This phase 2 trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.
Conditions
Conditions (3)
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 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphoseek | Drug | — | UNRESOLVED |
| Panitumumab-IRDye800 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- T1 or T2 stage and node-negative
- description
- T1 or T2 stage primary tumor and node-negative (ie, cN0)
- interventionNames
- Drug: Panitumumab-IRDye800
- Drug: Lymphoseek
- type
- EXPERIMENTAL
- label
- Any T stage and node-positive
- description
- Any T stage tumor and node-positive (ie, cN+)
- interventionNames
- Drug: Panitumumab-IRDye800
Primary outcomes (1)
- measure
- Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck * Patients with recurrent disease or a new primary will be allowed * Planned standard of care surgery with curative intent for squamous cell carcinoma * Cohort 1: T1-T2 stage tumor diagnosis, any subsite within the head and neck that is amenable to local sentinel node tracer injection, and scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy * Cohort 2 (neck dissection only): Diagnosis with any T-stage, any subsite within the head and neck that are scheduled to undergo surgical resection, including a (modified) neck dissection * Age ≥ 19 years * Karnofsky performance status of at least 70% or ECOG/Zubrod level 1 * Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: * Hemoglobin ≥ 9 gm/dL * White blood cell count \> 3000/mm³ * Platelet count ≥ 100,000/mm³ * Serum creatinine ≤ 1.5 times upper reference range EXCLUSION CRITERIA: * Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800 * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment * History of infusion reactions monoclonal antibody therapies * Pregnant or breastfeeding * Magnesium or potassium lower than the normal institutional values * Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents * History or evidence of interstitial pneumonitis or pulmonary fibrosis * Hypersensitivity to dextran and/or modified forms
References
Publications (0)
Data not yet available