search
Back to results

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Primary Purpose

High Grade Glioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET-MRI Brain Scan
Blood draw
Memory testing
Optional lumbar puncture for cerebrospinal fluid collection
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Grade Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed diagnosis of high grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme [GBM]).
  • ≥18 years of age.
  • ECOG performance status of 0 to 3
  • Anticipated to receive 6 weeks of chemoradiation

Exclusion Criteria:

  • Does not speak or read English
  • Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee.
  • Unable to give informed consent
  • Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor
  • Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan

  • Currently taking cognition-enhancing medications including:

    • Donepezil
    • Memantine
    • Armodafinil
    • Methylphenidate
  • Pregnant or nursing mothers.
  • Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation

Arm Description

PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.

Outcomes

Primary Outcome Measures

Number of Participants to Complete Two PET scans
Feasibility is defined as 70% of patients who complete two PET scans. This proportion and its 95% confidence interval will be calculated at 4 months
Number of Participants to Complete Cognitive Testing
Using a customized abbreviated cognitive battery designed for brain tumor patients to measure a range of cognitive functions affected by cancer and radiation treatment including basic attention, information processing speed, language, learning and recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills. Premorbid functioning (assessing cognitive reserve) will also be assessed via a single word reading test that is strongly associated with overall intellectual functioning. Most tests have multiple forms to allow for assessment at sequential time points. All tests have well-validated normative data and have been used previously with cancer patients. Fatigue, depression, anxiety, and quality of life will be evaluated simultaneously using standard and validated patient questionnaires

Secondary Outcome Measures

Change in PET measure Related to Cognitive Decline after Radiation Treatment
Change in cognitive decline is defined as one standard deviation on any neurocognitive test given using the 2-sample t-test (if normally distributed; transformation may be needed) or Wilcoxon rank sum test (if not normally distributed) when appropriate. Investigators will also relate baseline PET measure and change in PET measure to the cognitive change using the Spearman's rank correlation coefficient.
Change in Cerebrospinal Fluid Biomarkers Related to Cognitive Decline after Radiation Treatment
Changes in serum and cerebrospinal fluid biomarkers will be related to the cognitive decline at 4 months using the 2-sample t-test or Wilcoxon rank sum test when appropriate. We will also relate baseline and changes in serum and CSF biomarkers to the cognitive change using the Spearman's rank correlation coefficient.

Full Information

First Posted
January 14, 2022
Last Updated
February 24, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05212272
Brief Title
MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Official Title
A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.
Detailed Description
Primary Objective: To determine the feasibility of interim PET-MRI in high-grade glioma patients undergoing chemoradiation by quantifying the proportion of high-grade glioma patients who are alive at 4 months post-radiation treatment and who have completed two PET scans and abbreviated cognitive testing pre-radiation treatment and at 4 months post radiation treatment. Secondary Objectives To determine by machine learning if early changes on FDG-PET correlate with cognitive decline after radiation treatment. Cognitive impairment will be defined as a 1 standard deviation decline on any test. To determine if baseline serum or cerebrospinal fluid markers or the change from baseline to 1-month are associated with patients with cognitive decline at 4-months after radiation treatment (defined as a 1 standard deviation decline on any test) compared to those without decline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation
Arm Type
Experimental
Arm Description
PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.
Intervention Type
Procedure
Intervention Name(s)
PET-MRI Brain Scan
Intervention Description
Before starting radiation, participants will have a PET scan and MRI scan of the brain. After 2 to 3 weeks of radiation treatments, participants will have a repeat PET scan. Then 1 month after radiation participants will have another PET scan
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood draw
Intervention Description
Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
Intervention Type
Behavioral
Intervention Name(s)
Memory testing
Intervention Description
3 sessions with simple tests to evaluate how the brain is working. These tests primarily check things like memory, attention, and thought process. The whole set of tests will take 1 hour each time.
Intervention Type
Procedure
Intervention Name(s)
Optional lumbar puncture for cerebrospinal fluid collection
Intervention Description
Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.
Primary Outcome Measure Information:
Title
Number of Participants to Complete Two PET scans
Description
Feasibility is defined as 70% of patients who complete two PET scans. This proportion and its 95% confidence interval will be calculated at 4 months
Time Frame
4 months post-treatment
Title
Number of Participants to Complete Cognitive Testing
Description
Using a customized abbreviated cognitive battery designed for brain tumor patients to measure a range of cognitive functions affected by cancer and radiation treatment including basic attention, information processing speed, language, learning and recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills. Premorbid functioning (assessing cognitive reserve) will also be assessed via a single word reading test that is strongly associated with overall intellectual functioning. Most tests have multiple forms to allow for assessment at sequential time points. All tests have well-validated normative data and have been used previously with cancer patients. Fatigue, depression, anxiety, and quality of life will be evaluated simultaneously using standard and validated patient questionnaires
Time Frame
4 months post-treatment
Secondary Outcome Measure Information:
Title
Change in PET measure Related to Cognitive Decline after Radiation Treatment
Description
Change in cognitive decline is defined as one standard deviation on any neurocognitive test given using the 2-sample t-test (if normally distributed; transformation may be needed) or Wilcoxon rank sum test (if not normally distributed) when appropriate. Investigators will also relate baseline PET measure and change in PET measure to the cognitive change using the Spearman's rank correlation coefficient.
Time Frame
At baseline and 4 months post-treatment
Title
Change in Cerebrospinal Fluid Biomarkers Related to Cognitive Decline after Radiation Treatment
Description
Changes in serum and cerebrospinal fluid biomarkers will be related to the cognitive decline at 4 months using the 2-sample t-test or Wilcoxon rank sum test when appropriate. We will also relate baseline and changes in serum and CSF biomarkers to the cognitive change using the Spearman's rank correlation coefficient.
Time Frame
At baseline and 4 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed diagnosis of high grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme [GBM]). ≥18 years of age. ECOG performance status of 0 to 3 Anticipated to receive 6 weeks of chemoradiation Exclusion Criteria: Does not speak or read English Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee. Unable to give informed consent Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan Currently taking cognition-enhancing medications including: Donepezil Memantine Armodafinil Methylphenidate Pregnant or nursing mothers. Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
336-716-0892
Email
camjohns@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Nurse
Phone
336-713-3539
Email
arcarrol@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Cramer, MD
Organizational Affiliation
Wake Forest Baptist Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
336-716-0892
Email
camjohns@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Study Nurse
Phone
336-713-3539
Email
arcarrol@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Christina Cramer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

We'll reach out to this number within 24 hrs