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

Laborértékek

• 6. 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.

Egyéb

• 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.

• 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.