PNOC 011: Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC).
The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors.
详细描述
This is an open label trial to assess the safety and tolerability of the adult tolerated dose of Hyperpolarized Pyruvate (HP) for metabolic imaging in children with brain tumors who do not require sedation for their MR imaging. Nine patients will receive a single MR imaging examination that includes the acquisition of hyperpolarized 13C metabolic data in combination with anatomic, diffusion, perfusion and lactate edited 1H spectroscopic imaging data. The data will be processed using custom designed software to estimate changes in levels of lactate/pyruvate and to relate them to abnormalities observed in the data from other MR modalities.
The results of this study will provide the safety data required to move this type of metabolic imaging into therapeutic trials to assess the utility of HP 13C lactate/pyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≥ 3 years and ≤ 18 years of age with a diagnosis of a brain tumor and who do not require sedation for MR imaging
- •Karnofsky ≥ 70 for patients ≥ 16 years of age, and Lansky ≥ 70 for patients < 16 years of age (See Appendix 1 Performance Status Criteria)
- •Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent
- •Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of starting treatment. Effective contraception (men and women) must be used in subjects of child-bearing potential
- •Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
排除标准
- •Patients who are not able to comply with study and/or follow-up procedures
- •Patients receiving active therapy on an investigational trial at the time of enrollment should consult with the study chair regarding potential interactions with other study agents. Patients who are enrolled in a clinical trial but are off- therapy and in follow up are eligible.
- •Patients with history or evidence of cardiac dysfunction
研究组 & 干预措施
Imaging Arm
Patients will receive a one-time injection of Hyperpolarized Pyruvate prior to a single MR imaging examination that includes the acquisition of HP carbon-13 metabolic data.
干预措施: Hyperpolarized Pyruvate (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 9 months
Dose Limiting Toxicities will be assessed by monitoring for adverse events, scheduled laboratory assessments, vital sign measurements, ECGs, and physical examinations. The severity of the toxicities will be graded according to the NCI CTCAE v4.0. Adverse events and clinically significant laboratory abnormalities will be summarized by maximum intensity and relationship to study drug. Safety will be assessed during the infusion and at least for one hour after completion of the infusion as well as by phone 24 hours after the infusion. Descriptive statistics will be utilized to display the data on toxicity seen. Analyses will be performed for all patients having received at least one dose of study drug.
次要结局
- Secondary analyses will include assessment of imaging quality, which will be descriptive in nature.(12 months)
研究者
Sabine Mueller, MD, PhD
Assistant Professor
University of California, San Francisco