A Pilot Study Evaluating in Vivo PARP-1 Expression with18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Glioblastoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy.
研究概览
简要总结
The subject will be a candidate for this imaging study because they have agreed to participate in a treatment study involving TTFields (Optune device), a device that uses low intensity, wave like electrical fields, and a PARP inhibitor drug (niraparib). The research study is being conducted to test how a new radioactive imaging drug called 18F-Fluorthanatrace (18F-FTT) can be used to image sites of recurrent brain cancer before or after new treatment or surgery. 18F-FTT is a drug used with an imaging test called Positron Emission Tomography/Computed Tomography (PET/CT).
详细描述
Participants will undergo up to three [18F]FTT PET/CT scans at the following time points:
- Baseline: Subjects from either cohort may agree to undergo a baseline [18F]FTT PET/CT prior to the start of TTFields therapy to measure baseline FTT uptake. This scan is not required and may be omitted at the discretion of the investigator or based on subject availability.
- Post-TTFields: Subjects from both cohorts will undergo an [18F]FTT PET/CT scan 3-7 days after initiation of TTFields therapy and before surgical resection or initiation of niraparib. This scan will measure the FTT uptake after TTFields therapy is initiated. This scan is required.
- Post-PARPi: Subjects from Cohort A may agree to undergo an post-therapy [18F]FTT PET/CT scan 1- 21 days after the initiation of niraparib to collect pilot data on the changes in FTT uptake after TTFields and niraparib combination therapy. This scan is not required and may be omitted at the discretion of the investigator or based on subject availability.
For each [18F]FTT PET/CT imaging session, participants will undergo approximately 60 minutes of dynamic brain scanning starting nearly simultaneously with the injection of [18F]FTT. A second optional brain scan will be done at approximately 90 minutes post-injection. Each imaging session will include an injection of up to 12 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of [18F]FTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be ≥ 22 years of age
- •Participants will have a diagnosis of glioblastoma and be enrolled in the companion treatment trial, IRB
- •Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
排除标准
- •Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening.
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
- •Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
研究组 & 干预措施
Non-surgical candidates
In this arm, subjects that do not have a clinical indication for surgical resection of the recurrent tumor will start TTFields therapy 5-7 days prior to starting oral niraparib (a PARP inhibitor).
干预措施: 18F-FluorThanatrace (Drug)
Surgical candidates
In this arm, subjects who have a clinical indication for surgical resection of the recurrent tumor will receive TTFields therapy for 5-7 days prior to planned surgical resection, undergo resection, and then resume TTFields therapy and initiate niraparib post-operatively.
干预措施: 18F-FluorThanatrace (Drug)
结局指标
主要结局
Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy.
时间窗: 3 years
Evaluate uptake of \[18F\]FTT in recurrent glioblastoma after initiation of TTFields therapy.
次要结局
- Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness".(3 years)