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Trial Title:
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
NCT ID:
NCT05555550
Condition:
Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial
Conditions: Official terms:
Glioma
Conditions: Keywords:
Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial
18F-Fluciclovine
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-Fluciclovine
Description:
18F-Fluciclovine will be injected via IV prior to PET-MRI imaging
Arm group label:
18F-Fluciclovine
Other name:
Axumin
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
1 Year
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Contact:
Last name:
Ali Nabavizadeh, MD
Email:
nabavizadehs@chop.edu
Contact backup:
Email:
cancertrials@chop.edu
Start date:
July 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Children's Hospital of Philadelphia
Agency class:
Other
Collaborator:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Collaborator:
Agency:
Dragon Master Foundation
Agency class:
Other
Source:
Children's Hospital of Philadelphia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555550
