Recruiting
Phase 1

89Zr Panitumumab

Sponsor:

Eben Rosenthal

Code:

NCT05747625

Conditions

Head and Neck Squamous Cell Carcinoma

Metastatic Head and Neck Squamous Cell Carcinoma

Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Panitumumab

Zirconium Zr 89 Panitumumab

Positron Emission Tomography

Computed Tomography

Electronic Health Record Review

Study Details

Brief summary:

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 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).

Conditions

Head and Neck Squamous Cell Carcinoma

Metastatic Head and Neck Squamous Cell Carcinoma

Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Study ID

NCT05747625

Start date

May 9, 2023

Status verified date

May, 2026

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal
  • Hemoglobin >= 9gm/dL
  • White blood cell count > 3000/mm\^3
  • Platelet count >= 100,000/mm\^3
  • Serum creatinine =< 1.5 times upper reference range

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Diagnostic (89Zr panitumumab PET/CT)

Patients receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study

Interventions

Panitumumab

Given IV

Zirconium Zr 89 Panitumumab

Given IV

Positron Emission Tomography

Undergo PET/CT

Computed Tomography

Undergo PET/CT

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab [ Time Frame: Up to 7 years ]
  • Specificity of 89Zr-panitumumab [ Time Frame: Up to 7 years ]

Central Contacts and Locations

Central contacts

Nicole Jones

615-936-2807nicole.l.jones@vumc.org

Kyrionna Golliday

(615)421-1585kyrionna.m.golliday@vumc.org

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Michael Topf, MD

More Information

Sponsor

Eben Rosenthal

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eben Rosenthal on 2026-05-08.