Recruiting
Early Phase 1

18F-Fluciclovine

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05555550

Conditions

Glioma

Low-grade Glioma

Low Grade Glioma of Brain

Glioma, Malignant

Glioma Intracranial

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

18F-Fluciclovine

Study Details

Brief summary:

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 ID

NCT05555550

Start date

Jul 29, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-Fluciclovine

18F-Fluciclovine PET-MRI

Interventions

18F-Fluciclovine

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

Primary outcome measure

  • Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET [ Time Frame: 1 year ]
  • Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mariam Aboian, MD, PhD

215-510-7661aboianm@chop.edu

Nazanin Maleki, MD

malekin@chop.edu

Locations

The Children s Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mariam Aboian, MD, PhD

215-510-7661aboianm@chop.edu

Nazanin Maleki, MD

malekin@chop.edu

Principal Investigator:

Mariam Aboian, MD,PhD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Glioma
  • Low-grade Glioma
  • Low Grade Glioma of Brain
  • Glioma, Malignant
  • Glioma Intracranial
  • 18F-Fluciclovine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-29.