(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Trial Title: (89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05747625

Condition: Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Panitumumab

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Panitumumab
Description: Given IV
Arm group label: Diagnostic (89Zr panitumumab PET/CT)

Intervention type: Drug
Intervention name: Zirconium Zr 89 Panitumumab
Description: Given IV
Arm group label: Diagnostic (89Zr panitumumab PET/CT)

Intervention type: Procedure
Intervention name: Positron Emission Tomography
Description: Undergo PET/CT
Arm group label: Diagnostic (89Zr panitumumab PET/CT)

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo PET/CT
Arm group label: Diagnostic (89Zr panitumumab PET/CT)

Intervention type: Other
Intervention name: Electronic Health Record Review
Description: Ancillary studies
Arm group label: Diagnostic (89Zr panitumumab PET/CT)

Summary: The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).

Detailed description: PRIMARY OBJECTIVE: - Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zrpanitumumab) for the detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma. SECONDARY OBJECTIVE: - Compare sensitivity and specificity of standard of care imaging modalities (magnetic resonance imaging [MRI], CT and/or fludeoxyglucose F-18 [18F]-PET/CT) to 89Zr-panitumumab-PET/CT for detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma. EXPLORATORY OBJECTIVE: - Determine rate of intervention (e.g., biopsy or other invasive procedures) versus (vs) non-intervention (e.g., serial imaging, observation) by treatment team in subjects with indeterminate metastatic lesions on standard of care imaging. OUTLINE: Patients receive panitumumab intravenously (IV), 89Zr panitumumab IV, and undergo PET/CT on study.

Criteria for eligibility:
Criteria:
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 evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT - Hemoglobin >= 9gm/dL - White blood cell count > 3000/mm^3 - Platelet count >= 100,000/mm^3 - Serum creatinine =< 1.5 times upper reference range - Estimated glomerular filtration rate (eGFR) >= 60mL/min/1.73m^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 (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), 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

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Vanderbilt University/Ingram Cancer Center

Address:
City: Nashville
Zip: 37232
Country: United States

Status: Recruiting

Contact:
Last name: Vanderbilt-Ingram Service for Timely Access

Phone: 800-811-8480
Email: cip@vumc.org

Investigator:
Last name: Michael Topf, MD
Email: Principal Investigator

Start date: May 9, 2023

Completion date: March 1, 2030

Lead sponsor:
Agency: Michael Topf
Agency class: Other

Source: Vanderbilt-Ingram Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05747625