Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of 89Zr-panitumumab
研究概览
简要总结
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).
详细描述
PRIMARY OBJECTIVE(S):
- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions
SECONDARY OBJECTIVE(S):
- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
89Zr-panitumumab IV
Subjects will be given 89Zr-panitumumab IV
干预措施: 89Zr-panitumumab IV (Drug)
panitumumab 30 mg
Subjects will be given a 30mg of panitumumab
干预措施: Panitumumab (Drug)
结局指标
主要结局
Sensitivity and Specificity of 89Zr-panitumumab
时间窗: Up to 1 year
The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging.
次要结局
- Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging(Up to 1 year)
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University