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18F-Fluciclovine PET-MRI for Brain Tumor

Phase < 1
Waitlist Available
Led By Ali Nabavizadeh, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a special imaging agent called 18F-Fluciclovine (Axumin®) can help manage brain tumors in children. The agent is used in scans to make tumors more visible. Doctors will compare these images periodically to see how well the treatment is working.

Who is the study for?
This trial is for children and young adults aged 1 to 21 with Low Grade Gliomas (brain tumors). They must have a tumor visible on MRI, be scheduled for systemic therapy, and have a certain level of physical ability. It's not for pregnant individuals, those needing extra sedation for scans, with kidney issues or very low body weight, or who can't avoid contact with infants/pregnant women post-injection.
What is being tested?
The study tests the usefulness and safety of a diagnostic agent called 18F-Fluciclovine in PET-MRI scans before treatment starts and then at 3 months and 1 year after therapy begins. The changes in uptake will be compared to MRI measurements over time.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include reactions at the injection site, discomfort from lying still during imaging procedures, potential allergic reactions to the tracer substance used in PET-MRI scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET
Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG
Secondary study objectives
Safety of 18F-Fluciclovine
Other study objectives
Disease Progression
Response prediction

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT03263780
8%
Urinary tract infection
8%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-Fluciclovine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-FluciclovineExperimental Treatment1 Intervention
18F-Fluciclovine PET-MRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-Fluciclovine
2017
Completed Phase 2
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Low Grade Glioma (LGG) include chemotherapy agents such as carboplatin and vincristine, which work by interfering with the DNA replication process, thereby inhibiting tumor cell growth. Targeted agents like selumetinib, a MEK inhibitor, and everolimus, an mTOR inhibitor, disrupt specific signaling pathways that are crucial for tumor cell proliferation and survival. The use of 18F-Fluciclovine PET-MRI imaging is significant as it allows for precise monitoring of tumor activity and response to treatment, enabling personalized and timely adjustments to therapy. This is crucial for LGG patients as it helps in optimizing treatment efficacy while minimizing unnecessary side effects.

Find a Location

Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor
41 Previous Clinical Trials
3,032 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
728 Previous Clinical Trials
8,470,238 Total Patients Enrolled
Blue Earth Diagnostics, IncUNKNOWN
4 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

18F-Fluciclovine Clinical Trial Eligibility Overview. Trial Name: NCT05555550 — Phase < 1
Low Grade Glioma Research Study Groups: 18F-Fluciclovine
Low Grade Glioma Clinical Trial 2023: 18F-Fluciclovine Highlights & Side Effects. Trial Name: NCT05555550 — Phase < 1
18F-Fluciclovine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555550 — Phase < 1
~20 spots leftby Sep 2025
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