What side effects are associated with this type of intervention?

Common treatments for Low Grade Glioma (LGG) include chemotherapy agents such as carboplatin and vincristine, as well as targeted agents like selumetinib and everolimus. Known side effects of carboplatin and vincristine include nausea, vomiting, hair loss, and neuropathy. Selumetinib can cause skin rash, diarrhea, and elevated liver enzymes, while everolimus may lead to mouth ulcers, infections, and fatigue. These side effects are generally manageable but require monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved various treatments for Low Grade Glioma (LGG), primarily focusing on surgical resection, radiation therapy, and chemotherapy. Imaging techniques such as MRI are commonly used to monitor tumor activity. While 18F-Fluciclovine (Axumin®) is being studied for its potential in PET-MRI imaging to monitor LGG, there are no specific FDA approvals mentioned for this radiotracer in the context provided. Generally, PET-MRI and other advanced imaging modalities are crucial in assessing treatment response and disease progression in LGG.

What other types of research exist?

Promising novel alternatives to 18F-Fluciclovine for PET-MRI imaging in Low Grade Glioma patients include 68Ga-DOTATATE and 18F-FET. 68Ga-DOTATATE targets somatostatin receptors, which are often overexpressed in neuroendocrine tumors, and has shown potential in glioma imaging. 18F-FET (Fluoroethyltyrosine) is an amino acid PET tracer that has demonstrated high sensitivity and specificity for glioma imaging, making it a strong candidate for clinical use by 2024.

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18F-Fluciclovine PET-MRI for Brain Tumor

Q: What is the mechanism of action of this treatment?

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Urinary tract infection

Sepsis

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.