The Children s Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Mariam Aboian, MD, PhD
CONTACT
Mariam Aboian, MD,PhD
PRINCIPAL_INVESTIGATOR
Nazanin Maleki, MD
CONTACT
NCT Number: NCT05555550
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.
Interested in participating?
Request Info1 year–21 year
All sexes
Interventional
Early Phase 1
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Mariam Aboian, MD, PhD
CONTACT
Mariam Aboian, MD,PhD
PRINCIPAL_INVESTIGATOR
Nazanin Maleki, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
18F-Fluciclovine will be injected via IV prior to PET-MRI imaging
Other names: Axumin
Time frame: 1 year
To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan
Time frame: 1 year
Calculate the change in tumor measurement on MRI
Time frame: 13 months
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: 1 year
Determine if Baseline PET uptake as predictors of treatment response
Time frame: 1 year
Identify changes in PET metrics at the time of progression
Contact information is provided by the study sponsor or research team.
Mariam Aboian, MD, PhD
CONTACT
Nazanin Maleki, MD
CONTACT
Children's Hospital of Philadelphia
Other
Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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