Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Thomas Hope
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Percentage of accurate prediction of presence of tumor (Population 1)
研究概览
简要总结
This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.
详细描述
PRIMARY OBJECTIVES:
- To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas.
- To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2.
SECONDARY OBJECTIVES:
- To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1.
- To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence or suspicion of intracranial neoplasm in two populations:
- •Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.
- •Three sub-populations will be considered:
- •Recurrent metastatic lesions.
- •Recurrent high-grade gliomas (Grades 3 and 4).
- •Recurrent low-grade gliomas (Grade 2).
- •Population 2: Participants prior to primary treatment with planned biopsy or surgical resection.
- •Age > 3 years.
- •Participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.
排除标准
- •Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.
- •Participants unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
- •Sedation or anesthesia can be used for participants who cannot tolerate the exam.
研究组 & 干预措施
Population 1: Participants with intracranial neoplasms
Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.
干预措施: Fluorethyltyrosine (18-F) (Drug)
Population 1: Participants with intracranial neoplasms
Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.
干预措施: Positron Emission Tomography (PET) (Procedure)
Population 2: Participants with suspected glial neoplasms
Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery)
干预措施: Fluorethyltyrosine (18-F) (Drug)
Population 2: Participants with suspected glial neoplasms
Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery)
干预措施: Positron Emission Tomography (PET) (Procedure)
结局指标
主要结局
Percentage of accurate prediction of presence of tumor (Population 1)
时间窗: Up to 3 years
The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported
Maximum Intracranial lesion tumor-to-background ratio (TBRmax)
时间窗: Up to 3 years
The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue.
Percentage of radiological read responses
时间窗: Up to 3 years
The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported.
次要结局
未报告次要终点
研究者
Thomas Hope
Co-Principal Investigator, IND Holder
University of California, San Francisco