Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Thomas Hope
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)
研究概览
简要总结
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.
详细描述
PRIMARY OBJECTIVES:
I. To determine if FET PET can differentiate between benign treatment-related changes (TRC) and recurrent glioma in comparison to a composite standard of truth (CSOT) that includes pathology and other clinical information, evaluated using estimates of sensitivity and specificity (Combined populations)
SECONDARY OBJECTIVES:
I. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.(Combined populations).
II. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a CSOT evaluated using estimates other than subject-based sensitivity and specificity.(Combined populations).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 3 years.
- •Presence or suspicion of intracranial neoplasm in two populations.
- •Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered:
- •Recurrent metastatic lesions.
- •Recurrent high-grade gliomas (grades 3 and 4).
- •Recurrent low-grade gliomas (grades 1 and 2).
- •Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.
排除标准
- •Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
- •Patient 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 patients who cannot tolerate the exam.
研究组 & 干预措施
Population 1: Intracranial neoplasms (glial or metastatic disease)
Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.
干预措施: F-18 Fluoroethyltyrosine (FET) (Drug)
Population 1: Intracranial neoplasms (glial or metastatic disease)
Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.
干预措施: Positron Emission Tomography (PET) (Procedure)
Population 2: Suspected glial neoplasms
Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.
干预措施: F-18 Fluoroethyltyrosine (FET) (Drug)
Population 2: Suspected glial neoplasms
Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.
干预措施: Positron Emission Tomography (PET) (Procedure)
结局指标
主要结局
Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)
时间窗: Up to 6 months
Sensitivity is defined as a percentage of all participants with a true positive (TP) FET PET scan result relative to participants with a positive CSOT result = \[TP / (TP + FN)\] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Specificity of FET PET using a CSOT (subject-level)
时间窗: Up to 6 months
Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to participants with a negative CSOT result = \[TN / (TN + FP)\] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
次要结局
- Sensitivity of FET PET using a histopathology standard of truth (subject-level)(Up to 6 months)
- Sensitivity of FET PET using a histopathology standard of truth (lesion-level)(Up to 6 months)
- Specificity of FET PET using a histopathology standard of truth (subject-level)(Up to 6 months)
- Specificity of FET PET using a histopathology standard of truth (lesion-level)(Up to 6 months)
- Positive Predictive Value (PPV) using a histopathology standard of truth (subject-level)(Up to 6 months)
- Positive Predictive Value (PPV) using a histopathology standard of truth (lesion-level)(Up to 6 months)
- Negative Predictive Value (NPV) using a histopathology standard of truth (subject-level)(Up to 6 months)
- Negative Predictive Value (NPV) using a histopathology standard of truth (lesion-level)(Up to 6 months)
- Accuracy of FET PET using a histopathology standard of truth (subject-level)(Up to 6 months)
- Accuracy of FET PET using a histopathology standard of truth (lesion-level)(Up to 6 months)
- Misclassification rate for FET PET using a histopathology standard of truth (Subject-level)(Up to 6 months)
- Misclassification rate for FET PET using a histopathology standard of truth (lesion-level)(Up to 6 months)
- Sensitivity of FET PET using a CSOT (lesion-level)(Up to 6 months)
- Specificity of FET PET using a CSOT (lesion-level)(Up to 6 months)
- PPV of FET PET using a CSOT (subject-level)(Up to 6 months)
- PPV of FET PET using a CSOT (lesion-level)(Up to 6 months)
- NPV of FET PET using a CSOT (subject-level)(Up to 6 months)
- NPV of FET PET using a CSOT (lesion-level)(Up to 6 months)
- Accuracy of FET PET using a CSOT (subject-level)(Up to 6 months)
- Accuracy of FET PET using a CSOT (lesion-level)(Up to 6 months)
- Misclassification rate for FET PET using CSOT (subject-level)(Up to 6 months)
- Misclassification rate for FET PET using CSOT (lesion-level)(Up to 6 months)
- Degree of inter-rater reliability(Up to 6 months)
- Reproducibility of inter-rater reliability(Up to 6 months)
- Proportion of all participants with reported treatment-emergent adverse events (TEAEs)(Up to 48 hours after FET PET imaging)
研究者
Thomas Hope
Assistant Professor
University of California, San Francisco