Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial
Conditions
Keywords
Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial, 18F-Fluciclovine
Brief summary
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.
Interventions
DRUG18F-Fluciclovine
18F-Fluciclovine will be injected via IV prior to PET-MRI imaging
Sponsors
Blue Earth Diagnostics
Dragon Master Foundation
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance. 2. Participants must have evaluable disease (1x1 cm tumor on MRI) 3. Scheduled to receive systemic therapy for LGG 4. 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. 5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration 6. Being on a treatment regimen does not exclude a subject from enrollment.
Exclusion criteria
1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 2. Pregnant participants 3. Participants who weigh less than 8 kg. 4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. 5. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration. 6. Participants with primary tumors of the spinal cord.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET | 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 | 1 year | Calculate the change in tumor measurement on MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of 18F-Fluciclovine | 13 months | The Safety profile of 18F-Fluciclovine PET in pediatric LGG participants will be accessed by the CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine |
Other
| Measure | Time frame | Description |
|---|---|---|
| Response prediction | 1 year | Determine if Baseline PET uptake as predictors of treatment response |
| Disease Progression | 1 year | Identify changes in PET metrics at the time of progression |
Countries
United States
Contacts
Primary ContactMariam Aboian, MD, PhD
Backup ContactNazanin Maleki, MD
Outcome results
None listed