Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Sep 22, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a special imaging technique called 18F-Fluciclovine Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) to help manage low-grade gliomas (LGG) in children. These are slow-growing brain tumors that can affect how the brain functions. The trial will involve taking images of the brain using this method before starting treatment and again at 3 months and 1 year after treatment begins. Researchers want to see how well this imaging technique works in showing changes in the tumors compared to standard MRI scans.

To participate in this study, children aged between 1 and 21 who have been diagnosed with a low-grade glioma that can be seen on an MRI may be eligible. They should be scheduled to receive treatment and have a certain level of ability to perform daily activities. However, some individuals may not qualify, such as those with specific health issues or those who would need sedation for the imaging. Participants can expect to undergo imaging sessions and will be monitored for changes in their condition over time, helping to understand the effectiveness of this imaging technique for their treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance
• • Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)
• • Scheduled to receive systemic therapy
• • 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 between ≥ 1 years but ≤21 years at time of study registration
• Exclusion Criteria:
• • 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• • 2. Pregnant participants
• • 3. Patient who would require sedation or anesthesia for imaging beyond SOC.
• • 4. Participants who weigh less than 8 kg.
• • 5. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
• • 6. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
• • 7. Participants with primary tumors of the spinal cord.