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Proton Beam Therapy

Proton Therapy for Pediatric Brain Cancer

N/A

Recruiting

Led By Bree R Eaton, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary tumor located within the supratentorial brain

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 3 years from treatment

Awards & highlights

Study Summary

This trial studies how well spectroscopic MRI guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors.

Who is the study for?

This trial is for children with high-grade brain tumors (WHO grade 3-4) who are recommended to receive radiation therapy and can undergo MRI scans. It's open to all genders, races, and ethnic groups. The tumor must be in the upper part of the brain. Kids with significant illnesses that make MRI unsafe or have certain implants like pacemakers are not eligible.Check my eligibility

What is being tested?

The study is testing how well a special type of MRI called spectroscopic imaging works alongside proton therapy to see changes in the metabolism of brain tumors in kids without using contrast agents. This non-invasive method could help distinguish between healthy tissue and tumor metabolism.See study design

What are the potential side effects?

Since this trial focuses on assessing metabolic change through imaging rather than treatment effects, side effects may primarily relate to discomfort or risks associated with undergoing MRIs, such as anxiety in closed spaces or reactions if sedation is needed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain tumor is located above the cerebellum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 3 years from treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 3 years from treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 3 years from treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy

Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery

Incidence of adverse events

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diagnostic (sMRI)Experimental Treatment2 Interventions

Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.

Group II: Group 2Active Control2 Interventions

Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Spectroscopic Imaging

2012

Completed Phase 1

~430

Proton Therapy

2009

Completed Phase 2

~280

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,621 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,108 Total Patients Enrolled

Bree R Eaton, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04908709 — N/A

Brain Tumor Research Study Groups: Diagnostic (sMRI), Group 2

Brain Tumor Clinical Trial 2023: Proton Therapy Highlights & Side Effects. Trial Name: NCT04908709 — N/A

Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908709 — N/A

Frequently Asked Questions

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

Are any further applicants accepted for this research endeavor?

"That is accurate. Clinicaltrials.gov contains information that this medical trial, which was initially posted on December 20th 2018, is actively looking for volunteers. 25 individuals across 3 separate sites are required to complete the study."

Answered by AI

How many participants have committed to this medical experiment?

"Affirmative. Data available on clinicaltrials.gov suggests that this research initiative, which was originally posted in December of 2018, is actively searching for participants. A total of 25 patients will be recruited from 3 separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors

Bree Eaton 2018. "Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908709.

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