A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tumor to background ratio (TBR), measured in ex vivo tissues
研究概览
简要总结
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.
II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.
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
- •Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
- •Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
- •Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
- •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
排除标准
- •Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- •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, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- •Prisoners, institutionalized individuals, and patients unable to consent for themselves
研究组 & 干预措施
Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
干预措施: Near-Infrared Fluorescence Imaging (Procedure)
Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
干预措施: Panitumumab-IRDye800 (Drug)
Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
干预措施: Pharmacokinetic Study (Other)
Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Tumor to background ratio (TBR), measured in ex vivo tissues
时间窗: Up to 1 year
The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery).
次要结局
- Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug(Up to 30 days)
- Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments(Up to 1 year)
- Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments(Up to 1 year)
- Residual disease detection by Panitumumab-IRDye800 versus standard assessments(Up to 1 year)