What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as chemotherapy and radiotherapy, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infections due to lowered blood cell counts. Radiotherapy may lead to skin irritation, fatigue, and potential cognitive decline over time. Specific to 18F-fluciclovine PET imaging, side effects are generally minimal but can include mild injection site reactions and rare allergic responses. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for brain tumors that involve radiotracers for metabolic imaging include the use of 18F-fluorodeoxyglucose (FDG) PET imaging, which is commonly used to assess tumor metabolism and response to therapy. Another radiotracer, 18F-fluoro-L-thymidine (FLT), has shown promise in early and robust prediction of treatment efficacy in glioblastoma. These imaging agents help differentiate between tumor progression and treatment-related changes, similar to the investigational use of 18F-fluciclovine (Axumin®) PET imaging in high-grade gliomas.

What other types of research exist?

Promising alternatives to 18F-fluciclovine PET imaging for brain tumor patients include 4-(18)F-T140, which targets CXCR4 expression in tumors, and Gallium-68 labeled curcumin complexes, which have shown higher uptake in tumor cells and potential for diagnostic applications.

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PET-MRI with Axumin for Brain Tumor

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

Common treatments for brain tumors include radiotracers like 18F-fluciclovine (Axumin®) used in PET imaging, which help differentiate tumor growth from post-treatment changes by highlighting metabolic activity in cancer cells. Chemotherapy, such as temozolomide, works by damaging the DNA of rapidly dividing tumor cells, leading to cell death. Targeted therapies, like bevacizumab, inhibit angiogenesis, cutting off the tumor's blood supply. Immunotherapies, such as CAR T-cell therapy, enhance the immune system's ability to recognize and destroy cancer cells. These treatments are crucial as they offer various mechanisms to attack the tumor, improve diagnostic accuracy, and potentially increase survival rates for brain tumor patients.

Phase < 1

Recruiting

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 6 months

Awards & highlights

Study Summary

This trial will test if Axumin can help doctors better understand how children's High Grade Gliomas are progressing after treatment.

Who is the study for?

This trial is for children and young adults aged between 1 to 21 with high-grade gliomas (brain tumors) who are suspected of tumor progression. They must have a measurable disease, confirmed histopathology or characteristic imaging for DIPG, and a life expectancy over 8 weeks. It's not suitable for those unable to tolerate imaging procedures, under sedation beyond standard care, weighing less than 8 kg, or in close contact with pregnant women/infants post-injection.Check my eligibility

What is being tested?

The study tests the usefulness and safety of an imaging technique called 18F-fluciclovine PET-MRI in managing high-grade gliomas in children. The goal is to see if this method can accurately distinguish between actual tumor growth and changes that might look like progression but aren't harmful after treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, generally PET-MRI scans may cause discomfort due to the need to stay still during the procedure. There could also be risks associated with exposure to radiation from the scan itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Histopathology analysis

Image analysis

Secondary outcome measures

Safety of 18F-Fluciclovine

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participantsExperimental Treatment1 Intervention

Single intravenous administration of 18F fluciclovine for PET-MRI Scan

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

Common treatments for brain tumors include radiotracers like 18F-fluciclovine (Axumin®) used in PET imaging, which help differentiate tumor growth from post-treatment changes by highlighting metabolic activity in cancer cells. Chemotherapy, such as temozolomide, works by damaging the DNA of rapidly dividing tumor cells, leading to cell death. Targeted therapies, like bevacizumab, inhibit angiogenesis, cutting off the tumor's blood supply. Immunotherapies, such as CAR T-cell therapy, enhance the immune system's ability to recognize and destroy cancer cells. These treatments are crucial as they offer various mechanisms to attack the tumor, improve diagnostic accuracy, and potentially increase survival rates for brain tumor patients.

Dual kinin B1 and B2 receptor activation provides enhanced blood-brain barrier permeability and anticancer drug delivery into brain tumors.Analysis of gene profiles in glioma cells identifies potential genes, miRNAs, and target sites of migratory cells.

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Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,946 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

710 Previous Clinical Trials

8,588,934 Total Patients Enrolled

Blue Earth Diagnostics, IncUNKNOWN

4 Previous Clinical Trials

129 Total Patients Enrolled

Media Library

18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants Clinical Trial Eligibility Overview. Trial Name: NCT05553041 — Phase < 1

Brain Tumor Research Study Groups: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants

Brain Tumor Clinical Trial 2023: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants Highlights & Side Effects. Trial Name: NCT05553041 — Phase < 1

18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553041 — Phase < 1

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