Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Image Quality
研究概览
简要总结
This pilot clinical study will investigate if Zirconium-89 (89Zr) panitumumab- Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) imaging can more accurately determine size and location of primary tumors compared to standard of care Fludeoxyglucose (18F-FDG) -PET/MRI in newly diagnosed patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing surgical resection. This study is for imaging purposes only and is not a treatment study. The results of this study will not change the clinical treatment plan.
详细描述
The study is an open label, single center, non-randomized, pilot study to determine the efficacy of [89Zr]panitumumab to localize primary tumor in patients with squamous cell carcinoma of the head and neck (HNSCC) that undergo surgery with curative intent compared to standard of care,18F-FDG. Enrolled subjects are clinically and radiographically node negative (cN0) based on the preoperative work-up, which includes a standard of care physical exam and evaluation of the pre-existing imaging data (CT or MRI scan, which may be collected before or during standard of care [18F]FDG imaging).
Consenting and Screening phone call
Physicians who are study sub-investigators will identify and discuss the study with eligible patients they see in clinic. If interested in the study, sub-investigators will contact study coordinators to discuss further with patients. Interested participants will be consented prior to any study procedures. Consent may be signed during clinical visit or at a more convenient time by the participant.
Enrolled patients will be called to discuss the study and complete an MRI screening form. Participants meeting MRI screening criteria will be scheduled for the first visit.
Visit 1 (within 5-9 days prior to surgery)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
- •Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
- •Subjects are to be staged clinically and radiographically node negative (cN0)
- •Planned standard of care surgery with curative intent for squamous cell carcinoma
- •Age > 18 years
- •Have acceptable hematologic status, coagulation status (11 to 13.5 seconds. international normalized ratio (INR) of 0.8 to 1.1), kidney function, and liver function including the following clinical results:
- •Hemoglobin ≥ 9 gm/dL
- •White blood cell count ≥ 3000/mm3
- •Platelet count ≥ 100,000/mm3
- •Serum creatinine ≤ 1.5 times upper reference range
- •alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter.
排除标准
- •Received an investigational drug within 30 days prior to the first dose of [89Zr]panitumumab.
- •Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- •Previous HNSCC resection.
- •History of infusion reactions to monoclonal antibody therapies.
- •Pregnant or breast-feeding women.
- •Magnesium (<1.7 mg/dL) or potassium (<3.6 mmol/L) lower than the normal institutional values.
- •Subjects receiving Class I-A (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 (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
- •Known hypersensitivity to panitumumab or any of its components.
- •Weight over 350 lbs., due to the scanner bore size.
- •Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).
研究组 & 干预措施
[89Zr]panitumumab-PET/MRI patients
All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.
干预措施: [89Zr]Panitumumab Tracer (Drug)
结局指标
主要结局
Image Quality
时间窗: 5-9 days prior to surgery
Diagnostic image quality of \[89Zr\]Panitumumab PET imaging in patients with newly diagnosed HNSCC. Standardized Uptake Values (SUVs) will be measured.
次要结局
未报告次要终点
研究者
Suzanne E. Lapi, PhD
Professor, Advanced Imaging Facility, Division of Advanced Medical Imaging Research
University of Alabama at Birmingham