Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05555550 | RECRUITING | Glioma

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

Children's Hospital of Philadelphia

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.

Condition or disease

Glioma

Low-grade Glioma

Low Grade Glioma of Brain

Glioma, Malignant

Glioma Intracranial

Intervention/treatment

18F-Fluciclovine

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
Actual Study Start Date : 2025-03-03
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Year to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance
  • * Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)
  • * Scheduled to receive systemic therapy
  • * 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.
  • * Age between ≥ 1 years but ≤21 years at time of study registration
Exclusion Criteria
  • 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • 2. Pregnant participants
  • 3. Patient who would require sedation or anesthesia for imaging beyond 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.
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Location Details

NCT05555550

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Pennsylvania

The Children s Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104