NCT05183048RecruitingEarly phase 1
Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 20 Dec 2021
- Start date
- 20 Feb 2023
- Primary completion date
- Feb 2028
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Head and neck cancer
- NCT number
- NCT05183048
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 14
- From 20 Feb 2023 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects receiving Class I-A (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).
Other illness
- History of infusion reactions to monoclonal antibody therapies.
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Known hypersensitivity to panitumumab or any of its components.
Lab values
- Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values.
- Severe renal disease or anuria (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
Other
- Pregnant or breast-feeding women.
- Weight over 350 lbs., due to the scanner bore size.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAB Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.