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

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ClinicalTrials.gov Identifier: NCT04908709
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bree Eaton, Emory University

Brief Summary:
This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.

Condition or disease Intervention/treatment Phase
Malignant Brain Glioma Procedure: Magnetic Resonance Spectroscopic Imaging Device: Proton Therapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : October 13, 2022
Estimated Study Completion Date : October 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo sMRI
Other Names:
  • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Magnetic Resonance Spectroscopy
  • MRS
  • MRS Imaging
  • MRSI
  • Proton Magnetic Resonance Spectroscopic Imaging

Device: Proton Therapy
Target volume treatment
Other Names:
  • Spectroscopic MRI
  • Proton Radiation Therapy
  • sMRI imaging
  • Magnetic Resonance Spectroscopy
  • 3D whole brain MR spectroscopic imaging sequence

Active Comparator: 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.
Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo sMRI
Other Names:
  • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Magnetic Resonance Spectroscopy
  • MRS
  • MRS Imaging
  • MRSI
  • Proton Magnetic Resonance Spectroscopic Imaging

Device: Proton Therapy
Target volume treatment
Other Names:
  • Spectroscopic MRI
  • Proton Radiation Therapy
  • sMRI imaging
  • Magnetic Resonance Spectroscopy
  • 3D whole brain MR spectroscopic imaging sequence




Primary Outcome Measures :
  1. Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy [ Time Frame: Through study completion, an average of 1 year ]
    The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.

  2. Incidence of adverse events [ Time Frame: Through study completion, an average of 1 year ]
    Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  3. Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery [ Time Frame: From Baseline up to 3 years from treatment ]
    Will be estimated by the Kaplan-Meier Method.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically diagnosed high-grade glioma (World Health Organization [WHO] grade 3-4). Patients with a radiographically diagnosed high-grade glioma may enroll prior to pathologic confirmation, but would be removed from study if pathology did not confirm the diagnosis of high-grade glioma.
  • 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 with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, or other incompatible implants which makes MRI safety an issue are excluded.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908709


Contacts
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Contact: Bree Eaton, MD 404-778-3473 brupper@emory.edu

Locations
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United States, Georgia
Emory Proton Therapy Center Recruiting
Atlanta, Georgia, United States, 30308
Contact: Ardith R. DeShay    404-251-0753    adeshay@emory.edu   
Principal Investigator: Bree R. Eaton, MD         
Children's Healthcare of Atlanta - Scottish Rite Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Christina Lomba    404-785-4803    christina.lomba@choa.org   
Principal Investigator: Bree R. Eaton         
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Hillary Gaines       hillary.gaines@emoryhealthcare.org   
Principal Investigator: Bree R. Eaton, MD         
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bree R Eaton, MD Emory University Hospital/Winship Cancer Institute
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Responsible Party: Bree Eaton, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04908709    
Other Study ID Numbers: IRB00106849
NCI-2018-02065 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB00106849
RAD4500-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue