An Assessment of the Efficacy of Floretyrosine F 18 ([18F]FET) Positron Emission Tomography (PET) for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 4
- 主要终点
- Primary Objective
研究概览
简要总结
This study is designed to prospectively analyze [18F]FET PET image data obtained retrospectively in the routine clinical care of glioma patients. The study will analyse the data from participants with grade (1-4) glioma after primary treatment according to local clinical practice and with suspicion of progression/recurrence on magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed patient informed consent with secondary use of data permitted. Pediatric patients (<18 years of age) will provide assent along with parental/legal guardian /caregiver consent
- •Male or Female of any age at the time of [18F]FET PET imaging. While there is no age restriction, it is expected that enrollment of patients ≤ 3 years old will be rare due to the very low incidence of glioma in this age group.
- •Documented histologic diagnosis or clinical suspicion of glioma (Grades 1-4) based on local clinical assessment.
- •Underwent [18F]FET PET imaging as part of routine clinical care after completion of primary treatment (surgery, radiation therapy, and/or chemotherapy).
- •Evidence of radiographic suspicion of recurrence or progression on MRI at the time of [18F]FET PET imaging.
- •The adult patient, 18 years of age or older, has received nominal injected dose of 4 to 7 mCi (148 - 259 MBq ) of [18F]FET per imaging time point.
- •The pediatric patients, 0-17 years old, must have received a pediatric dose adjusted based upon the patient's body weight.
排除标准
- •Participants will be excluded if they did not meet any of the inclusion criteria or institutional requirements for participation.
- •Did not meet all inclusion criteria.
- •Did not undergo [18F]FET PET imaging as part of routine clinical care.
- •Imaging data or associated clinical information is incomplete, non-evaluable, or of insufficient quality for analysis.
- •Any institutional or regulatory requirement that precludes data sharing or inclusion in retrospective research studies.
研究组 & 干预措施
Group 1
Retrospective review of patients with histologically confirmed or suspected glioma (Grades 1-4) who underwent [18F]FET PET imaging as part of routine clinical care following completion of primary treatment (surgery, radiation, and/or chemotherapy), and who demonstrated radiographic suspicion of progression or recurrence on conventional imaging.
干预措施: 18F(FET)PET (Diagnostic Test)
结局指标
主要结局
Primary Objective
时间窗: 4 months
The performance of \[18F\]FET PET in its ability to differentiate between benign treatment-related changes (TRC) and recurrent glioma (Grades 1-4) in comparison to a composite standard of truth (CSOT) will be evaluated and sensitivity and specificity evaluated.
次要结局
未报告次要终点