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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- LGG (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:

- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.

- Pregnant participants.

- Patient who would require sedation or anesthesia for imaging beyond standard of care (SOC).

- 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.

- Participants with a history of abnormal kidney function or creatinine above expected values for age and gender.

- Participants with primary tumors of the spinal cord.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05555550
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Hospital of Philadelphia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ali Nabavizadeh, MD
Principal Investigator Affiliation	Children's Hospital of Philadelphia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial

Arms & Interventions

Arms

Experimental: 18F-Fluciclovine

18F-Fluciclovine PET-MRI

Interventions

Drug: - 18F-Fluciclovine

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Ali Nabavizadeh, MD

[email protected]

215-590-1000

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