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Trial ID: NCT04840472
Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
- 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 elective neck dissection for a cN0 or cN1 disease. Clinical
N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or
less in greatest dimension by clinical exam, cross sectional imaging or metabolic
- 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
- 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 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.
drug: 111I-n panitumumab
procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans
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