NCT05183048

Brief Summary

This pilot clinical study will investigate if Zirconium-89 (89Zr) panitumumab- Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) imaging can more accurately determine size and location of primary tumors compared to standard of care Fludeoxyglucose (18F-FDG) -PET/MRI in newly diagnosed patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing surgical resection. This study is for imaging purposes only and is not a treatment study. The results of this study will not change the clinical treatment plan.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at P25-P50 for early_phase_1

Timeline
20mo left

Started Feb 2023

Longer than P75 for early_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 Progress66%
Feb 2023Feb 2028

First Submitted

Initial submission to the registry

December 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

December 20, 2021

Last Update Submit

December 18, 2025

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Image Quality

    Diagnostic image quality of \[89Zr\]Panitumumab PET imaging in patients with newly diagnosed HNSCC. Standardized Uptake Values (SUVs) will be measured.

    5-9 days prior to surgery

Study Arms (1)

[89Zr]panitumumab-PET/MRI patients

EXPERIMENTAL

All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.

Drug: [89Zr]Panitumumab Tracer

Interventions

[89Zr]Panitumumab TracerDRUG

All patients entered into the study will have \[89Zr\]Panitumumab-PET/MRI imaging.

[89Zr]panitumumab-PET/MRI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
  • Subjects are to be staged clinically and radiographically node negative (cN0)
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • Age \> 18 years
  • Have acceptable hematologic status, coagulation status (11 to 13.5 seconds. international normalized ratio (INR) of 0.8 to 1.1), kidney function, and liver function including the following clinical results:
  • Hemoglobin ≥ 9 gm/dL
  • White blood cell count ≥ 3000/mm3
  • Platelet count ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 times upper reference range
  • alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter.

You may not qualify if:

  • Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumumab.
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
  • Previous HNSCC resection.
  • History of infusion reactions to monoclonal antibody therapies.
  • Pregnant or breast-feeding women.
  • Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values.
  • Subjects receiving Class I-A (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 (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
  • Known hypersensitivity to panitumumab or any of its components.
  • Weight over 350 lbs., due to the scanner bore size.
  • Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Study Officials

  • Suzanne Lapi, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Eady, BS

CONTACT

204-996-2636smeady@uabmc.edu

Chase Bower

CONTACT

205-645-4457charlesbower@uabmc.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Advanced Imaging Facility, Division of Advanced Medical Imaging Research

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 10, 2022

Study Start

February 20, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)