NCT05747625

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
47mo left

Started May 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
May 2023Mar 2030

First Submitted

Initial submission to the registry

February 16, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 9, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

February 16, 2023

Last Update Submit

December 13, 2025

Conditions

Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Sensitivity of 89Zr-panitumumab

    Up to 7 years

  • Specificity of 89Zr-panitumumab

    Up to 7 years

Study Arms (1)

Diagnostic (89Zr panitumumab PET/CT)

EXPERIMENTAL

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

Biological: PanitumumabDrug: Zirconium Zr 89 PanitumumabProcedure: Positron Emission TomographyProcedure: Computed TomographyOther: Electronic Health Record Review

Interventions

PanitumumabBIOLOGICAL

Given IV

Diagnostic (89Zr panitumumab PET/CT)
Zirconium Zr 89 PanitumumabDRUG

Given IV

Diagnostic (89Zr panitumumab PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Diagnostic (89Zr panitumumab PET/CT)
Computed TomographyPROCEDURE

Undergo PET/CT

Diagnostic (89Zr panitumumab PET/CT)
Electronic Health Record ReviewOTHER

Ancillary studies

Diagnostic (89Zr panitumumab PET/CT)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

PanitumumabMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Michael Topf, MD

    Vanderbilt University/Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Jones

CONTACT

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

Kyrionna Golliday

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Barry and Amy Baker Professor and Chair

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 28, 2023

Study Start

May 9, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 1, 2030

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

US(1)