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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05555550
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Glioma
  • Glioma Intracranial
  • Glioma, Malignant
  • Low Grade Glioma of Brain
  • Low-grade Glioma

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 29, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: 18F-Fluciclovine
    18F-Fluciclovine PET-MRI

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The 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)

Find similar trials in Philadelphia, PA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
The Children s Hospital of Philadelphia· Philadelphia, PA

Related Studies