Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of grade 2 or higher adverse events
研究概览
简要总结
This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.
详细描述
Primary Objective:
- Assess the safety of the dual modality imaging (DMI) molecular agents, indium In 111 panitumumab (111In-panitumumab) and panitumumab-IRDye800, in patients with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVES:
- Determine the sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for the detection of subclinical disease during primary tumor removal.
- Determine sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for detection of lymph nodes.
OUTLINE:
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
- 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 that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed
- •Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive 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
- •Hemoglobin >= 9 gm/dL
- •White blood cell count > 3000/mm^3
- •Platelet count >= 100,000/mm^3
- •Serum creatinine =< 1.5 times upper reference range
- •Ability to understand and the willingness to sign a written informed consent document
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
- •Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
- •History of infusion reactions to monoclonal antibody therapies
- •History of allergies to iodine
- •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
- •Thyroid stimulating hormone (TSH) > 13 micro international units/mL
研究组 & 干预措施
Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
干预措施: Panitumumab-IRDye800 (Drug)
Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
干预措施: Indium In 111 Panitumumab (Other)
Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
干预措施: Single Photon Emission Computed Tomography (Procedure)
Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
干预措施: Computed Tomography (Procedure)
Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
干预措施: Resection (Procedure)
Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
干预措施: Fluorescence Imaging (Procedure)
结局指标
主要结局
Number of grade 2 or higher adverse events
时间窗: Up to day 15
Will assess the number of grade 2 or higher adverse events determined to be significant and definitely or probably related to the study drugs. Adverse events will be evaluated using the Common Terminology Criteria for Adverse Events version 5.0 and summarized by grade, severity, and type.
次要结局
- Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins(Up to 4 years)
- Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins(Up to 4 years)
- Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes(Up to 4 years)
- Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes(Up to 4 years)
研究者
Eben Rosenthal
Professor and Chair Department of Otolaryngology-
Vanderbilt-Ingram Cancer Center