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NCT Number: NCT05423197

89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC

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).

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Key information

Conditions

Head-and-neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Cancer Institute

San Francisco, California, 94305, United States

Location contact

Andrei Iagaru, MD

SUB_INVESTIGATOR

Benjamin L Franc, MD, MS, MBA

SUB_INVESTIGATOR

Carina Aparici, MD

SUB_INVESTIGATOR

Chris Holsinger, MD

SUB_INVESTIGATOR

Dimitrios Colevas, MD

SUB_INVESTIGATOR

Farshad Moradi, MD, PhD

SUB_INVESTIGATOR

Fred Baik, MD

PRINCIPAL_INVESTIGATOR

Fred Baik, MD

SUB_INVESTIGATOR

Grace Yi

CONTACT

[email protected]

650-723-1423

Guido Davidzon, MD

SUB_INVESTIGATOR

Jagruti Shah, MBBS

SUB_INVESTIGATOR

Roan C Raymundo, BS

CONTACT

[email protected]

650-721-4071

Saad Khan, MD

SUB_INVESTIGATOR

Vasu Divi, MD

SUB_INVESTIGATOR

Yu-Jin Lee, MD, MS

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

89Zr-panitumumab IV

Drug

Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions

Panitumumab

Drug

Panitumumab 30mg will be given orally

Primary outcomes

  1. Sensitivity and Specificity of 89Zr-panitumumab

    Time frame: Up to 1 year

    The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging.

Secondary outcomes

  1. Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging

    Time frame: Up to 1 year

    The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 18F-FDG using PET/CT imaging. The specificity and sensitivity of 89Zr-panitumumab will be compared to the specificity and sensitivity of 18F-FDG for identification of metastatic lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Yi

CONTACT

[email protected]

650-723-1423

Roan C Raymundo, BS

CONTACT

[email protected]

(650) 721-4071

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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