NCT05183048 Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT05183048 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2023-02-20 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck 2. Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. 3. Subjects are to be staged clinically and radiographically node negative (cN0) 4. Planned standard of care surgery with curative intent for squamous cell carcinoma 5. Age \> 18 years 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: 1. Hemoglobin ≥ 9 gm/dL 2. White blood cell count ≥ 3000/mm3 3. Platelet count ≥ 100,000/mm3 4. Serum creatinine ≤ 1.5 times upper reference range 5. alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter. Exclusion Criteria: 1. Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumumab. 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. Previous HNSCC resection. 4. History of infusion reactions to monoclonal antibody therapies. 5. Pregnant or breast-feeding women. 6. Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values. 7. Subjects receiving Class I-A (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. 8. Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. 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. Known hypersensitivity to panitumumab or any of its components. 11. Weight over 350 lbs., due to the scanner bore size. 12. Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).
Contact & Investigator
Suzanne Lapi, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05183048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05183048 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05183048 currently recruiting?
Yes, NCT05183048 is actively recruiting participants. Contact the research team at smeady@uabmc.edu for enrollment information.
Where is the NCT05183048 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05183048 clinical trial?
NCT05183048 is sponsored by University of Alabama at Birmingham. The principal investigator is Suzanne Lapi, PhD at University of Alabama at Birmingham. The trial plans to enroll 14 participants.