NCT05747625 (89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT05747625 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Eben Rosenthal |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2027-02-28 |
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 60 participants in total. It began in 2023-05-09 with a primary completion date of 2027-02-28.
⚠ 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
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).
Eligibility Criteria
Inclusion Criteria: * 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 evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal * Hemoglobin \>= 9gm/dL * White blood cell count \> 3000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Serum creatinine =\< 1.5 times upper reference range Exclusion Criteria: * 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 (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), 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 & Investigator
Michael Topf, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Frequently Asked Questions
Who can join the NCT05747625 clinical trial?
This trial is open to participants of all sexes, aged 19 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 NCT05747625 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 NCT05747625 currently recruiting?
Yes, NCT05747625 is actively recruiting participants. Contact the research team at nicole.l.jones@vumc.org for enrollment information.
Where is the NCT05747625 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05747625 clinical trial?
NCT05747625 is sponsored by Eben Rosenthal. The principal investigator is Michael Topf, MD at Vanderbilt University/Ingram Cancer Center. The trial plans to enroll 60 participants.