Clinical trial · Interventional
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck | Head and Neck Cutaneous Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Panitumumab | Biological | Panitumumab | ALIAS |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Zirconium Zr 89 Panitumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (89Zr panitumumab PET/CT)
- description
- Patients receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study
- interventionNames
- Biological: Panitumumab
- Drug: Zirconium Zr 89 Panitumumab
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
- Other: Electronic Health Record Review
Primary outcomes (2)
- measure
- Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab
- timeFrame
- Up to 7 years
- description
- The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using positron emission tomography (PET)/computed tomography (CT) imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available