Recruiting
Early Phase 1

18F-Fluciclovine

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05553041

Conditions

Glioma

High Grade Glioma

Glioma, Malignant

Glioma Intracranial

Diffuse Glioma

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

18F-Fluciclovine PET-MRI

Study Details

Brief summary:

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.

Conditions

Glioma

High Grade Glioma

Glioma, Malignant

Glioma Intracranial

Diffuse Glioma

Study ID

NCT05553041

Start date

Aug 7, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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 \>= CTCAE v5.0 grade 2 at time of study registration.

7\. 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 PET-MRI in pediatric HGG or DMG participants

Single intravenous administration of 18F fluciclovine for PET-MRI Scan

Interventions

18F-Fluciclovine PET-MRI

18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)

Primary outcome measure

  • Image analysis [ Time Frame: 6 months ]
  • Histopathology analysis [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Mariam Aboian, MD, PhD

215-510-7661aboianm@chop.edu

Nazanin Maleki, MD

malekin@chop.edu

Locations

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

Dec 4, 2025

Last verified

Dec, 2025

Keywords

  • Glioma
  • High Grade Glioma
  • Glioma, Malignant
  • Glioma Intracranial
  • Diffuse Glioma
  • 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 2025-12-04.