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

This is an interventional diagnostic trial for Glioma focused on measuring Glioma, High Grade Glioma, Glioma, Malignant, Glioma Intracranial, Diffuse Glioma, 18F fluciclovine Read More

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 above expected values for age and gender.