Using a new imaging agent to detect metastases in head and neck cancer
Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
This study is testing a new imaging agent to see if it can help find hidden cancer spread in people with head and neck cancer better than current methods.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | panitumumab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05747625 on ClinicalTrials.gov |
What this trial studies
This phase I clinical trial evaluates the effectiveness of zirconium Zr 89 panitumumab combined with PET/CT imaging for diagnosing metastatic lesions in patients with head and neck squamous cell carcinoma. Participants will receive an infusion of 89Zr panitumumab and undergo PET/CT scans to assess the sensitivity and specificity of this investigational imaging agent compared to standard imaging methods. The study aims to improve the accuracy of detecting indeterminate metastatic lesions, which is crucial for determining appropriate treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with biopsy-confirmed squamous cell carcinoma of the head and neck and evidence of indeterminate metastatic disease.
Not a fit: Patients with recent significant cardiovascular events or those with a history of severe reactions to monoclonal antibody therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of metastatic head and neck cancer, allowing for better treatment planning.
How similar studies have performed: While traditional imaging methods have limitations, this study explores a novel approach that has not been widely tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Michael Topf, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Nicole Jones
- Email: nicole.l.jones@vumc.org
- Phone: 615-936-2807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.