Clinical trial · Interventional
89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC
Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
NCT05423197CI-TRIAL-00122295withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): logistical issues
Summary
Brief summary (as posted)
The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-panitumumab IV | Drug | — | UNRESOLVED |
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- panitumumab 30 mg
- description
- Subjects will be given a 30mg of panitumumab
- interventionNames
- Drug: Panitumumab
- type
- EXPERIMENTAL
- label
- 89Zr-panitumumab IV
- description
- Subjects will be given 89Zr-panitumumab IV
- interventionNames
- Drug: 89Zr-panitumumab IV
Primary outcomes (1)
- measure
- Sensitivity and Specificity of 89Zr-panitumumab
- timeFrame
- Up to 1 year
- description
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 standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions. * Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results: * Hemoglobin ≥ 9gm/dL * White blood cell count \> 3000/mm3 * Platelet count ≥ 100,000/mm3 * Serum creatinine ≤ 1.5 times upper reference range * PTT = 11.5 - 14.4 seconds * INR = 0.9 - 1.2 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 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
No reference posted for this study.