Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Trial ID: NCT05555550

Interventional - Phase 1 - Recruiting

The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.

Conditions

• Glioma
• Low-grade Glioma
• Low Grade Glioma of Brain
• Glioma, Malignant
• Glioma Intracranial

Interventions

• 18F-Fluciclovine

Eligibility

Inclusion criteria

• 1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
• 2. Participants must have evaluable disease (1x1 cm tumor on MRI)
• 3. Scheduled to receive systemic therapy for LGG
• 4. Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• 5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration
• 6. Being on a treatment regimen does not exclude a subject from enrollment.

Exclusion criteria

• 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• 2. Pregnant participants
• 3. Participants who weigh less than 8 kg.
• 4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
• 5. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
• 6. Participants with primary tumors of the spinal cord.

Sponsor

Children's Hospital of Philadelphia, Blue Earth Diagnostics, Dragon Master Foundation

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows