Clinical trial NCT05555550: Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Official title: Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial
Keywords: Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial
18F-Fluciclovine
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
name: Dragon Master Foundation
First posted: 2022-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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 \&gt; 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 \&gt;= CTCAE v5.0 grade 2 at time of study registration.
7. Participants with primary tumors of the spinal cord.

Primary outcomes:
measure: Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET
timeFrame: 1 year
measure: Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG
timeFrame: 1 year
Secondary outcomes:
measure: Safety of 18F-Fluciclovine
timeFrame: 13 months
Other outcomes:
measure: Response prediction
timeFrame: 1 year
measure: Disease Progression
timeFrame: 1 year
Locations:
city: Philadelphia
country: United States
facility: The Children s Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: The Children s Hospital of Philadelphia
name: Mariam Aboian, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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