18F-Fluciclovine PET-MRI in High-grade Glioma

NCT05553041 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 21-019514
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 Intracranial; Diffuse Glioma; Glioma; High Grade Glioma; Glioma, Malignant

Keywords

Glioma; High Grade Glioma; Glioma, Malignant; Glioma Intracranial; Diffuse Glioma; 18F fluciclovine

Outcome Measures

Primary Outcomes (2)

• Image analysis

  Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.

  6 months

• Histopathology analysis

  Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.

  4 weeks

Secondary Outcomes (1)

• Safety of 18F-Fluciclovine

  6 months

Study Arms (1)

18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants

EXPERIMENTAL

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

Drug: 18F-Fluciclovine PET-MRI

Interventions

18F-Fluciclovine PET-MRI DRUG

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

Also known as: Axumin

18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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).
• \. Measurable disease, measuring at least 1x1 cm.
• \. Life expectancy of greater than 8 weeks.
• \. Age \> 1 years but \< 21 years of age at enrollment.
• For those without planned surgery:
• \. 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.
• \. Participants with suspicion for TP or PsP on first post-radiation MRI
• For those with planned surgery:
• \. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.

You may not qualify if:

• \. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
• \. Pregnant or breastfeeding participants.
• \. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).
• \. 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Blue Earth Diagnostics: collaborator
• Dragon Master Foundation: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Glioma

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Mariam Aboian, MD,PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Aboian, MD, PhD

CONTACT

215-510-7661; aboianm@chop.edu

Nazanin Maleki, MD

CONTACT

malekin@chop.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: August 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)