Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)

21-019514

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.

2023-08-07

2025-12-01

2026-12-01

Recruiting

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-08-14