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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05553041
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Diffuse Glioma
  • Glioma
  • Glioma Intracranial
  • Glioma, Malignant
  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 7, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants
    Single intravenous administration of 18F fluciclovine for PET-MRI Scan

Primary Outcome Measure

Image analysis [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Mariam Aboian, MD, PhD
[email protected]
215-510-7661
Nazanin Maleki, MD
[email protected]
Mariam Aboian, MD,PhD (PRINCIPAL_INVESTIGATOR)

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