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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747625
• Other study ID #: VICCHN2279
• Secondary ID: NCI-2023-01365
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2023
• Est. completion date: March 1, 2030

Study information

• Verified date: July 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Vanderbilt-Ingram Services for Timely Access
• Phone: 800-811-8480
• Email: cip[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2030
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Metastatic Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• Panitumumab
Given IV

Drug:
• Zirconium Zr 89 Panitumumab
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT
• Computed Tomography
Undergo PET/CT

Other:
• Electronic Health Record Review
Ancillary studies

Locations

Country	Name	City	State
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Michael Topf

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab	The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using positron emission tomography (PET)/computed tomography (CT) imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates.	Up to 7 years
Primary	Specificity of 89Zr-panitumumab	The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using PET/CT imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates.	Up to 7 years
Secondary	Sensitivity of 89Zr-panitumumab	The sensitivity of 89Zr-panitumumab will be compared to the sensitivity of standard of care imaging modalities, including magnetic resonance imaging (MRI), CT, and/or fludeoxyglucose F-18 (18F-FDG) PET/CT. Will use the matched pair Durkalski's test, accounting for the cluster-correlation within subjects, for the sensitivity comparisons.	Up to 7 years
Secondary	Specificity of 89Zr-panitumumab	The specificity of 89Zr-panitumumab will be compared to the specificity of standard of care imaging modalities, including MRI, CT, and/or 18F-FDG PET/CT. Will use the matched pair Durkalski's test, accounting for the cluster-correlation within subjects, for the specificity comparisons.	Up to 7 years