18F-Fluciclovine PET-MRI in High-grade Glioma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-21
SponsorChildren's Hospital of Philadelphia
About this trial
The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 18F-Fluciclovine PET-MRI
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
Blue Earth Diagnostics
Collaborator
Dragon Master Foundation
Collaborator
Source ClinicalTrials.gov