18F-Fluciclovine PET-MRI in High-grade Glioma

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Sep 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a special type of imaging called 18F-fluciclovine PET-MRI to see if it can help doctors better manage high-grade gliomas in children. High-grade gliomas are aggressive brain tumors that can change after treatment, making it hard for doctors to tell if the tumor is growing or if the changes are just part of the treatment. The goal of the study is to determine if this imaging method is safe and effective for understanding these changes.

To be eligible for the trial, participants must be between 1 and 20 years old, have a confirmed diagnosis of high-grade glioma, and have measurable disease (meaning the tumor can be seen and measured). They should also have a life expectancy of more than 8 weeks. Participants will undergo imaging tests to help doctors assess their condition. It's important to note that some individuals may not qualify due to certain health issues or if they are pregnant or breastfeeding. This study is currently recruiting participants, and it aims to provide valuable information on how to improve care for children with these challenging tumors.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating \>=2/3 of the pons).
• • 2. Measurable disease, measuring at least 1x1 cm.
• • 3. Life expectancy of greater than 8 weeks.
• • 4. Age \> 1 years but \< 21 years of age at enrollment.
• For those without planned surgery:
• • 1. Participants with clinical and/or radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan.
• • or
• • 2. Participants with suspicion for TP or PsP on first post-radiation MRI
• For those with planned surgery:
• • 1. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.
• Exclusion Criteria:
• • 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
• • 2. Pregnant or breastfeeding participants.
• • 3. Participant who would require sedation or anesthesia for imaging beyond standard of care (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.