Glioma Clinical Trial
Official title:
Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Blue Earth Diagnostics, Inc, Dragon Master Foundation |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Image analysis | Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging. | 6 months | |
Primary | Histopathology analysis | Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology. | 4 weeks | |
Secondary | Safety of 18F-Fluciclovine | The Safety profile of 18F-Fluciclovine PET in pediatric HGG participants will be assessed based on CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine | 6 months |
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