Phase 1
N=14
Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck · Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT03733210 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
May 2023
Primary outcome: Primary: Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling — 0; 4; 0; 0 Lymph Nodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Panitumumab-IRDye800 (Drug); 89-Zirconium (Zr-89) Panitumumab (Drug); 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 (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Andrei Iagaru
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling |
0; 4; 0; 0; 0; 6 | — |
| SECONDARY Sensitivity and Specificity of 89Zr-panitumumab, 18F-FDG, and Panitumumab-IRDye800 |
0; 0.4; 0; 1.0; 0; 1.0 | — |
Summary
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].
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03733210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.