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NCT Number: NCT05555550

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

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.

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Key information

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Children s Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Mariam Aboian, MD, PhD

CONTACT

[email protected]

215-510-7661

Mariam Aboian, MD,PhD

PRINCIPAL_INVESTIGATOR

Nazanin Maleki, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
  • Participants must have evaluable disease (1x1 cm tumor on MRI)
  • Scheduled to receive systemic therapy for LGG
  • 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: Participants must be ≥ 1 years but ≤21 years of age at registration
  • Being on a treatment regimen does not exclude a subject from enrollment.

Exclusion criteria

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

Treatment and study plan

18F-fluciclovine

Drug

18F-Fluciclovine will be injected via IV prior to PET-MRI imaging

Other names: Axumin

Primary outcomes

  1. Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET

    Time frame: 1 year

    To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan

  2. Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG

    Time frame: 1 year

    Calculate the change in tumor measurement on MRI

Secondary outcomes

  1. Safety of 18F-Fluciclovine

    Time frame: 13 months

    The Safety profile of 18F-Fluciclovine PET in pediatric LGG participants will be accessed by the CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine

Other outcomes

  1. Response prediction

    Time frame: 1 year

    Determine if Baseline PET uptake as predictors of treatment response

  2. Disease Progression

    Time frame: 1 year

    Identify changes in PET metrics at the time of progression

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Aboian, MD, PhD

CONTACT

[email protected]

215-510-7661

Nazanin Maleki, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Blue Earth Diagnostics
  • Dragon Master Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 27, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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