NCT05423197

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
18mo left

Started Jun 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3.9 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

June 14, 2022

Last Update Submit

July 12, 2025

Conditions

Head-and-neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity of 89Zr-panitumumab

    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.

    Up to 1 year

Secondary Outcomes (1)

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

    Up to 1 year

Study Arms (2)

panitumumab 30 mg

ACTIVE COMPARATOR

Subjects will be given a 30mg of panitumumab

Drug: Panitumumab

89Zr-panitumumab IV

EXPERIMENTAL

Subjects will be given 89Zr-panitumumab IV

Drug: 89Zr-panitumumab IV

Interventions

89Zr-panitumumab IVDRUG

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

89Zr-panitumumab IV
PanitumumabDRUG

Panitumumab 30mg will be given orally

panitumumab 30 mg

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 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

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 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)

Stanford Cancer Institute

San Francisco, California, 94305, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Panitumumab

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 GlobulinsGlobulins

Study Officials

  • Fred Baik, MD

    Stanford Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roan C Raymundo, BS

CONTACT

(650) 721-4071rcraymun@stanford.edu

Grace Yi

CONTACT

650-723-1423gracesyi@stanford.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

US(1)