Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors
NCT ID: NCT04908709
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2018-12-20
2030-10-13
Brief Summary
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Detailed Description
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I. To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention)
SECONDARY OBJECTIVES:
I. To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient.
II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence.
III. To evaluate sMRI as a tool in identifying pseudoprogression vs. true progression and correlate post-treatment sMRI metabolite ratios with histopathology if collected.
IV. To report patterns of failure in relationship to the RT field (local, marginal, or distant), progression-free survival (PFS) and overall survival (OS) among all patients.
V. To report patient reported outcomes of health related quality of life (QOL) during and after proton therapy for pediatric HGG.
VI. To build a longitudinal tracking database including clinical data, imaging, and genomic molecular profiling for pediatric HGG treatment.
OUTLINE:
Patients undergo sMRI prior to radiation therapy, at 1, 4, and 7 months after RT, and at the time of suspected recurrence.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diagnostic (sMRI)
Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
Magnetic Resonance Spectroscopic Imaging
Undergo sMRI
Proton Therapy
Target volume treatment
Group 2
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.
Magnetic Resonance Spectroscopic Imaging
Undergo sMRI
Proton Therapy
Target volume treatment
Interventions
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Magnetic Resonance Spectroscopic Imaging
Undergo sMRI
Proton Therapy
Target volume treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary tumor located within the supratentorial brain.
* Recommended to receive definitive radiation therapy.
* Able to receive MRI scans.
* Both males and females, and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria
* Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately tolerate MRI scan are excluded.
* Pathology demonstrated low-grade glioma or other benign or non-invasive brain tumor.
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Bree Eaton
Principal Investigator
Principal Investigators
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Bree R Eaton, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory Proton Therapy Center
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2018-02065
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB00106849
Identifier Type: -
Identifier Source: secondary_id
RAD4500-18
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00106849
Identifier Type: -
Identifier Source: org_study_id
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