Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.
研究概览
简要总结
The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma.
The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •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 that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
- •Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging.
- •Have acceptable hematologic status, coagulation status, 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
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 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.
研究组 & 干预措施
111-In panitumumab
The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.
干预措施: 111I-n panitumumab (Drug)
111-In panitumumab
The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.
干预措施: Single photon emission computed tomography/computed tomography (SPECT/CT) scans (Procedure)
结局指标
主要结局
Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.
时间窗: 15 days
Number of CTCAE v5.0 Grade 2 or higher adverse events by Day 15 determined that are significant, definitely or probably related to 111In panitumumab. Safety data will be summarized by grade, severity, and type.
次要结局
- Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye(10 days after surgery)
- Compare specificity of systemic 111In panitumumab versus conventional local optical dye(10 days after surgery)