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PET-MRI with Axumin for Brain Tumor
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
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
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
709 Previous Clinical Trials
8,587,687 Total Patients Enrolled
Blue Earth Diagnostics, IncUNKNOWN
4 Previous Clinical Trials
140 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 8 kg.I am between 1 and 21 years old.I am suspected of cancer progression but haven't had my first MRI after radiation.I am suspected to have tumor growth and am planned for surgery or biopsy.I need extra sedation or anesthesia for scans beyond what is normally given.My kidney function is not normal, or my creatinine levels are high for my age and gender.My diagnosis is a high-grade glioma or diffuse midline glioma, confirmed by tests.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this clinical study restricted to those who are under 35 years of age?
"This medical research only accepts participants aged 1 to 21 years old. There are a total of 135 studies for minors and 241 trials aimed at seniors above the age of 65."
Answered by AI
What is the eligibility criteria for participants in this research?
"Patients aged between 1 year and 21 years with a diagnosis of glioma can apply to this clinical trial. Approximately 30 applicants will be accepted into the program."
Answered by AI
Is this experiment currently accepting participants?
"According to clinicaltrials.gov, this particular research endeavour is no longer actively recruiting candidates. Initially posted on October 1st 2022 and last updated on September 21st 2022, the study has since closed its enrollment window; however, there are 360 other studies that remain open for patient recruitment currently."
Answered by AI
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