Clinical trial · Interventional
Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in 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 study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods \[positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations\].
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of the Head and Neck | Head and Neck Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89-Zirconium (Zr-89) Panitumumab | Drug | — | UNRESOLVED |
| Da Vinci Firefly Imaging System | Device | — | UNRESOLVED |
| Explorer Air camera | Device | — | UNRESOLVED |
| FIS-00 fluorescence imaging system (FIS) | Device | — | UNRESOLVED |
| IGP-ELVIS-v4 Macroscopic Specimen Imager | Device | — | UNRESOLVED |
| Leica fluorescence microscope | Device | — | UNRESOLVED |
| Odyssey CLx Imaging System | Device | — | UNRESOLVED |
| Panitumumab-IRDye800 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tumor-negative Lymph Nodes (by 18F-FDG scan)
- description
- Participants whose lymph nodes are negative for cancer
- interventionNames
- Drug: Panitumumab-IRDye800
- Drug: 89-Zirconium (Zr-89) Panitumumab
- Device: Pinpoint IR IR9000 fluorescence imaging system (FIS)
- Device: SPY-PHI IR9000 fluorescence imaging system (FIS)
- Device: Explorer Air camera
- Device: PDE-NEO II camera
- Device: FIS-00 fluorescence imaging system (FIS)
- Device: Da Vinci Firefly Imaging System
- Device: IGP-ELVIS-v4 Macroscopic Specimen Imager
- Device: Vevo 3100 LAZR-X
- Device: Pearl Triology Imaging System
- Device: Odyssey CLx Imaging System
- Device: Leica fluorescence microscope
- type
- EXPERIMENTAL
- label
- Tumor-positive Lymph Nodes (by 18F-FDG scan)
- description
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. * Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed. * Planned standard of care surgery with curative intent for squamous cell carcinoma. * 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: * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. * Previous bilateral neck dissection. * History of infusion reactions to monoclonal antibody therapies. * Pregnant or breastfeeding. * Magnesium or potassium lower than the normal institutional values. * Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. * Severe renal disease or anuria. * Known hypersensitivity to deferoxamine or any of its components.
References
Publications (0)
Data not yet available