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18F-Fluciclovine PET-MRI for Brain Tumor

Q: Is the enrollment period for this research still open?

The information found on clinicaltrials.gov reveals this trial is not actively searching for participants at the moment. Originally posted October 1st 2022, and last modified three days later, 358 other medical studies are still currently accepting patients into their trials.

Q: Who is eligible to join this clinical experimentation?

Aspiring participants must have a brain of suitable development, and be situated between the ages of 1 year old to 21 years. This medical study is looking for about 30 individuals that meet these criteria.

Q: Does this medical experiment have an age restriction, and if so, what is it?

The suitable age range for this trial is between 1 Year and 21 years.

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

Study Summary

This trial will test if 18F-Fluciclovine is a useful and safe treatment for children with Low Grade Gliomas.

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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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 outcome measures

Safety of 18F-Fluciclovine

Other outcome measures

Disease Progression

Response prediction

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT03263780

Sepsis

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

18F-Fluciclovine

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

Find a Location

Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,957 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,581,245 Total Patients Enrolled

Blue Earth Diagnostics, IncUNKNOWN

4 Previous Clinical Trials

140 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period for this research still open?

"The information found on clinicaltrials.gov reveals this trial is not actively searching for participants at the moment. Originally posted October 1st 2022, and last modified three days later, 358 other medical studies are still currently accepting patients into their trials."

Answered by AI

Who is eligible to join this clinical experimentation?

"Aspiring participants must have a brain of suitable development, and be situated between the ages of 1 year old to 21 years. This medical study is looking for about 30 individuals that meet these criteria."

Answered by AI