Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Adverse events related to ABY-029
研究概览
简要总结
The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach brain tumors so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
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
- 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
- •Clinical diagnosis of presumed high-grade glioma, based on image data.
- •Tumor judged to be suitable and planned for open cranial resection.
- •Valid informed consent by participant.
- •Age ≥ 18 years old.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Individuals who are pregnant or breast feeding.
- •Participants on any experimental or approved anti-EGFR targeted therapies
- •Elevated kidney or liver function tests (levels greater than 2.5 times the normal limit) from laboratory tests conducted as part of standard-of-care screening of prospective surgical participants no earlier than 30 days prior to surgery.
- •Any condition which, in the opinion of the clinical investigator, contraindicates research participation.
研究组 & 干预措施
ABY-029 6X dose group
ABY-029 will be administered at the 6X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
干预措施: ABY-029 (Drug)
ABY-029 10X dose group
ABY-029 will be administered at the 10X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
干预措施: ABY-029 (Drug)
结局指标
主要结局
Adverse events related to ABY-029
时间窗: One month
To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
False negative rate of ABY-029 fluorescence
时间窗: Up to three months
To measure of diagnostic performance of ABY-029, the false negative rate of ABY-029 fluorescence measured during surgery in tissue samples that are confirmed to be tumor through pathology.
次要结局
未报告次要终点
研究者
Linton T. Evans
Principal Investigator
Dartmouth-Hitchcock Medical Center