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

Glioma Clinical Trial

Official title:

Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05555550
• Other study ID #: 21-019390
• Secondary ID: 21NO104
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2023
• Source: Children's Hospital of Philadelphia
• Contact: Ali Nabavizadeh, MD
• Phone: 215-590-1000
• Email: nabavizadehs[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Glioma Intracranial
• Glioma, Malignant
• Low Grade Glioma of Brain
• Low-grade Glioma

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Blue Earth Diagnostics, Dragon Master Foundation

Country where clinical trial is conducted

United States, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response prediction	Determine if Baseline PET uptake as predictors of treatment response	1 year
Other	Disease Progression	Identify changes in PET metrics at the time of progression	1 year
Primary	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	1 year
Primary	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	1 year
Secondary	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	13 months