Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-21
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
Participants must have evaluable disease (1x1 cm tumor on MRI)
Scheduled to receive systemic therapy for LGG
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.
Disqualifiers
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Pregnant participants
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.
Trial design
Design model
Single group
Treatments tested in this trial
18F-Fluciclovine
Drug18F-Fluciclovine will be injected via IV prior to PET-MRI imaging
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: 18F-FluciclovineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET
To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan
Time frame
1 year2
Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG
Calculate the change in tumor measurement on MRI
Time frame
1 yearSecondary outcomes
1
Safety of 18F-Fluciclovine
The Safety profile of 18F-Fluciclovine PET in pediatric LGG participants will be accessed by the CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine
Time frame
13 monthsOther outcomes
1
Response prediction
Determine if Baseline PET uptake as predictors of treatment response
Time frame
1 year2
Disease Progression
Identify changes in PET metrics at the time of progression
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Blue Earth Diagnostics
Collaborator
Dragon Master Foundation
Collaborator
Source ClinicalTrials.gov