Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Andrei Iagaru

Status and phase: Not yet enrolling; Phase 2

Conditions: Head-and-neck Squamous Cell Carcinoma

Treatments: Drug: 89Zr-panitumumab IV; Drug: Panitumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05423197

IRB-63234

ENT0095 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

Full description

PRIMARY OBJECTIVE(S):

• Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions

SECONDARY OBJECTIVE(S):

• Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 19 years.

• 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. Subjects with recurrent disease or a new primary will be allowed.

• Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.

• Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:

  • Hemoglobin ≥ 9gm/dL
  • White blood cell count > 3000/mm3
  • Platelet count ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 times upper reference range
  • PTT = 11.5 - 14.4 seconds
  • INR = 0.9 - 1.2

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
• History of infusion reactions to other 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

panitumumab 30 mg

Active Comparator group

Description:

Subjects will be given a 30mg of panitumumab

Treatment:

Drug: Panitumumab

89Zr-panitumumab IV

Experimental group

Description:

Subjects will be given 89Zr-panitumumab IV

Treatment:

Drug: 89Zr-panitumumab IV