Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions.
研究概览
简要总结
This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.
详细描述
This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the infusion, subjects will be monitored for immediate adverse events, and a member of the study team will continue safety follow-up through postoperative assessments and a Day 15 follow-up contact. Participants will otherwise continue to receive standard-of-care evaluation and treatment for their intracranial disease at the discretion of their treating physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.
- •Subject age ≥ 18 years.
- •Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:
- •Chemistry Panel - Potassium, BUN (or urea), and Creatinine
- •CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
- •Magnesium and Phosphorus
- •Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.
- •Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.
排除标准
- •Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.
- •History of infusion reactions to any monoclonal antibody therapies.
- •Women who are currently pregnant or breastfeeding.
- •Participants presenting with a baseline QTcF interval > than 480 milliseconds.
- •Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.
- •Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- •Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- •Patients with severe renal disease or anuria
结局指标
主要结局
Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions.
时间窗: From infusion to 15 days post-infusion.
Safety will be defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered definitely or probably related to pan800. Safety data will be summarized by grade, severity, and type.
次要结局
- Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue.(Within 14 days post-surgery)
- Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio.(Within 14 days post-surgery)
- Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio.(Within 14 days post-surgery)
研究者
Eben Rosenthal
Barry and Amy Baker Professor and Chair
Vanderbilt-Ingram Cancer Center