Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Description

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

Study Overview

Study Details

Study overview

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.

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

Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Condition
Glioma
Intervention / Treatment

-

Contacts and Locations

Philadelphia

The Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance
  • * Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)
  • * Scheduled to receive systemic therapy
  • * 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.
  • * Age between ≥ 1 years but ≤21 years at time of study registration
  • 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • 2. Pregnant participants
  • 3. Patient who would require sedation or anesthesia for imaging beyond 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 \>= CTCAE v5.0 grade 2 at time of study registration.
  • 7. Participants with primary tumors of the spinal cord.

Ages Eligible for Study

1 Year to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Mariam Aboian, MD,PhD, PRINCIPAL_INVESTIGATOR, The Children s Hospital of Philadelphia

Study Record Dates

2026-09