Assessment of Primary and Metastatic Brain Tumor Hypoxia With 18F-Fluoromisonidazole, [18F]Fluoro-2-deoxy-D-glucose (FDG) and [15O]Water (H215O)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Determination of multi-tracer update times as related to overall survival and time to progression
研究概览
简要总结
Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health Organization] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (Magnetic resonance imaging) have residual tumor > 1.0 cm in diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (> 1.0 cm in diameter who will be receiving radiotherapy. The ability to accurately assess tumor hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change patient management once validated as tumor hypoxia is known to be associated with a poor prognosis [Eyler 2008].
详细描述
Malignant Brain Tumors (Primary and Metastatic) Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy administration, and chemotherapy methods, many brain tumors remain incurable. Many brain tumors are highly infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as surgery, focal radiotherapy, radiosurgery or brachytherapy.
Rationale and Goals of Study The preliminary efficacy of the radiopharmaceutical, 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole, [18F]FMISO, FMISO (fluoromisonidazole), a radiopharmaceutical that directly assess tumor hypoxia using Positron Emission Tomography(PET) will be assessed.
This preliminary/exploratory clinical study will investigate [F-18]FMISO in 30 evaluable patients with newly diagnosed primary brain tumor or brain metastasis. We expect that up to 35 -40 total patients may be enrolled in this study. This will assure that 30 evaluable patients (patients who have complete imaging results and blood metabolism data available for data analysis). In certain patients the blood metabolism data is not acceptable for final analysis typically due to difficulty in drawing it rapidly enough due to the vein collapsing during the rapid sampling required.
When possible we will also correlate FMISO uptake with the typical in-vitro test used to assess proliferation, Ki-67 (protein) and other experimental assessments of hypoxia. This correlation will be made whenever possible in those patients where tumor tissue is obtained as part of standard care.
OBJECTIVES:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients. The patient must have a newly diagnosed primary malignant brain tumors (WHO Grade III or IV glial-based tumors) and not have had a complete surgical resection and by contrast MRI (obtained within 14 days prior to the FMISO study)
- •Patients must be 18 years or older for inclusion in this research study.
- •Patients must document their willingness to be followed until death or time of progression.
- •All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- •Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans.
- •Pre-treatment laboratory tests for patients receiving [18F]FMISO must be performed within 21 days prior to study entry.
排除标准
- •Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
- •Patients who are pregnant or lactating or who suspect they might be pregnant.
- •Adult patients who require monitored anesthesia for PET scanning.
- •Patients who are too claustrophobic to undergo MRI or PET imaging
- •Patients who cannot undergo MRI imaging due to MRI exclusion criteria
研究组 & 干预措施
All Participants
All enrolled participants will complete three imaging sessions on separate days, beginning with a research MRI, then a PET scan with FDG and [15O]water, and a PET scan with FMISO. The two PET scans will be in any order on different days within one week of each other, and preferably on consecutive days. The research MRI will be within 14 days of the first PET scan.
干预措施: [18F]fluoro-2-deoxy-D-glucose (FDG) (Drug)
All Participants
All enrolled participants will complete three imaging sessions on separate days, beginning with a research MRI, then a PET scan with FDG and [15O]water, and a PET scan with FMISO. The two PET scans will be in any order on different days within one week of each other, and preferably on consecutive days. The research MRI will be within 14 days of the first PET scan.
干预措施: 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole (Drug)
All Participants
All enrolled participants will complete three imaging sessions on separate days, beginning with a research MRI, then a PET scan with FDG and [15O]water, and a PET scan with FMISO. The two PET scans will be in any order on different days within one week of each other, and preferably on consecutive days. The research MRI will be within 14 days of the first PET scan.
干预措施: [15O]water (Drug)
All Participants
All enrolled participants will complete three imaging sessions on separate days, beginning with a research MRI, then a PET scan with FDG and [15O]water, and a PET scan with FMISO. The two PET scans will be in any order on different days within one week of each other, and preferably on consecutive days. The research MRI will be within 14 days of the first PET scan.
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Determination of multi-tracer update times as related to overall survival and time to progression
时间窗: estimated 2 years
determine the association of FMISO PET uptake (hypoxic volume \[HV\]), highest tumor:blood ratio \[T/Bmax\]), FDG uptake, and tumor blood flow/perfusion determined with H215O and MRI and correlate these variables with overall survival (OS) and time to progression (TTP) in participants with newly diagnosed primary brain tumors or brain metastases.
次要结局
未报告次要终点