Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Eben Rosenthal2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2023年5月9日最近更新: 2026年5月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 60
试验地点: 2
主要终点: Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

PRIMARY OBJECTIVE:

- Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zrpanitumumab) for the detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma.

SECONDARY OBJECTIVE:

- Compare sensitivity and specificity of standard of care imaging modalities (magnetic resonance imaging [MRI], CT and/or fludeoxyglucose F-18 [18F]-PET/CT) to 89Zr-panitumumab-PET/CT for detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma.

EXPLORATORY OBJECTIVE:

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Supportive Care
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 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

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 (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