Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
概览
- 阶段
- 早期 1 期
- 干预措施
- 18F-Fluciclovine
- 疾病 / 适应症
- Glioma
- 发起方
- Children's Hospital of Philadelphia
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET
- 状态
- 招募中
- 最后更新
- 3天前
概览
简要总结
The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.
研究者
入排标准
入选标准
- •LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
- •Participants must have evaluable disease (1x1 cm tumor on MRI)
- •Scheduled to receive systemic therapy for LGG
- •Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- •Age: Participants must be ≥ 1 years but ≤21 years of age at registration
- •Being on a treatment regimen does not exclude a subject from enrollment.
排除标准
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- •Pregnant participants
- •Participants who weigh less than 8 kg.
- •Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
- •Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
- •Participants with primary tumors of the spinal cord.
研究组 & 干预措施
18F-Fluciclovine
18F-Fluciclovine PET-MRI
干预措施: 18F-Fluciclovine
结局指标
主要结局
Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET
时间窗: 1 year
To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan
Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG
时间窗: 1 year
Calculate the change in tumor measurement on MRI
次要结局
- Safety of 18F-Fluciclovine(13 months)