RECRUITING

Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma

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Conditions

Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma

Quick Facts

Study Start:2024-12-31
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05183048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
  2. 2. Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
  3. 3. Subjects are to be staged clinically and radiographically node negative (cN0)
  4. 4. Planned standard of care surgery with curative intent for squamous cell carcinoma
  5. 5. Age \> 18 years
  6. 6. 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:
  7. 1. Hemoglobin ≥ 9 gm/dL
  8. 2. White blood cell count ≥ 3000/mm3
  9. 3. Platelet count ≥ 100,000/mm3
  10. 4. Serum creatinine ≤ 1.5 times upper reference range
  11. 5. alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter.
  1. 1. Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumumab.
  2. 2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
  3. 3. Previous HNSCC resection.
  4. 4. History of infusion reactions to monoclonal antibody therapies.
  5. 5. Pregnant or breast-feeding women.
  6. 6. Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values.
  7. 7. Subjects receiving Class I-A (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  8. 8. Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  9. 9. Severe renal disease or anuria (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
  10. 10. Known hypersensitivity to panitumumab or any of its components.
  11. 11. Weight over 350 lbs., due to the scanner bore size.
  12. 12. Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).

Contacts and Locations

Study Contact

Sebastian Eady, BS
CONTACT
204-996-2636
smeady@uabmc.edu
Chase Bower
CONTACT
205-645-4457
charlesbower@uabmc.edu

Principal Investigator

Suzanne Lapi, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

UAB
Birmingham, Alabama, 35249
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Suzanne Lapi, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-31
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-12-31
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Squamous Cell Carcinoma