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

Primary Purpose

Malignant Brain Glioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Spectroscopic Imaging
Proton Therapy
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Brain Glioma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory Proton Therapy CenterRecruiting
  • Children's Healthcare of Atlanta - Scottish Rite
  • Emory University Hospital/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diagnostic (sMRI)

Group 2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.
Incidence of adverse events
Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
Will be estimated by the Kaplan-Meier Method.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2021
Last Updated
November 29, 2022
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04908709
Brief Title
Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors
Official Title
Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
October 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Brain Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (sMRI)
Arm Type
Experimental
Arm Description
Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Spectroscopic Imaging
Other Intervention Name(s)
1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Description
Undergo sMRI
Intervention Type
Device
Intervention Name(s)
Proton Therapy
Other Intervention Name(s)
Spectroscopic MRI, Proton Radiation Therapy, sMRI imaging, Magnetic Resonance Spectroscopy, 3D whole brain MR spectroscopic imaging sequence
Intervention Description
Target volume treatment
Primary Outcome Measure Information:
Title
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
Description
The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.
Time Frame
Through study completion, an average of 1 year
Title
Incidence of adverse events
Description
Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
Through study completion, an average of 1 year
Title
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
Description
Will be estimated by the Kaplan-Meier Method.
Time Frame
From Baseline up to 3 years from treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bree Eaton, MD
Phone
404-778-3473
Email
brupper@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bree R Eaton, MD
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Proton Therapy Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardith R. DeShay
Phone
404-251-0753
Email
adeshay@emory.edu
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton, MD
Facility Name
Children's Healthcare of Atlanta - Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Lomba
Phone
404-785-4803
Email
christina.lomba@choa.org
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hillary Gaines
Email
hillary.gaines@emoryhealthcare.org
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton, MD

12. IPD Sharing Statement

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

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