High Grade GliomaNCT05212272
MRI in High-Grade Glioma Patients Undergoing Chemoradiation
A study testing PET-MRI Brain Scan, Blood draw and Memory testing in people with High Grade Glioma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- PET-MRI Brain Scan, Blood draw and Memory testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Principal Investigator, 336-716-5772, Christina.Cramer@wfusm.edu
Christina Cramer, MD
About this study
Official title: A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
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, optional lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.
Read the 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.
- Conditions
- High Grade Glioma
- Being tested
- PET-MRI Brain Scan, Blood draw, Memory testing, Optional lumbar puncture for cerebrospinal fluid collection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRI Brain ScanProcedure or surgery
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, at 1 month and 3 to 4 months after radiation, participants will have another MRI scan.
Blood drawDiagnostic test
Blood draws will be taken at baseline, one month after radiation treatment, and 3 to 4 months after radiation treatment.
Memory testingBehavioural
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 at baseline, one month after radiation, and 3 to 4 months after radiation.
Optional lumbar puncture for cerebrospinal fluid collectionProcedure or surgery
Participants that consent for cerebrospinal fluid collection will have between 6 to 20 ml of cerebrospinal collected at baseline.
| Study group | Role | What they receive |
|---|---|---|
| PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation | Experimental | PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing. Receives: Procedure: PET-MRI Brain Scan; Diagnostic Test: Blood draw; Behavioral: Memory testing; Procedure: Optional lumbar puncture for cerebrospinal fluid collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and at 4 months post-treatment
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
Measured: At baseline and at 4 months post-treatment
Secondary outcomes (2)
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.
Measured: At baseline and 4 months post-treatment
Change in Cerebrospinal Fluid (CSF) 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.
Measured: At baseline and 4 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start2 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Cramer, MD, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212272
- Sponsor's protocol ID
- IRB00080134
- Other IDs
- WFBCCC 91221, P30CA012197
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
- ClinicalTrials.gov ID
- NCT05212272
- Acronym / sponsor ID
- IRB00080134
- Conditions
- High Grade Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, optional 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation | Experimental | Procedure: PET-MRI Brain Scan, Diagnostic Test: Blood draw, Behavioral: Memory testing, Procedure: Optional lumbar puncture for cerebrospinal fluid collectionPET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRI Brain ScanBefore 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, at 1 month and 3 to 4 months after radiation, participants will have another MRI scan. | Procedure or surgery | PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation |
| Blood drawBlood draws will be taken at baseline, one month after radiation treatment, and 3 to 4 months after radiation treatment. | Diagnostic test | PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation |
| Memory testing3 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 at baseline, one month after radiation, and 3 to 4 months after radiation. | Behavioural | PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation |
| Optional lumbar puncture for cerebrospinal fluid collectionParticipants that consent for cerebrospinal fluid collection will have between 6 to 20 ml of cerebrospinal collected at baseline. | Procedure or surgery | PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation |
Primary outcome
Number of Participants to Complete Two PET scans
Time frame: At baseline and at 4 months post-treatment
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
Time frame: At baseline and at 4 months post-treatment
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
2 secondary outcomes
Change in PET measure Related to Cognitive Decline after Radiation Treatment
Time frame: At baseline and 4 months post-treatment
Change in Cerebrospinal Fluid (CSF) Biomarkers Related to Cognitive Decline after Radiation Treatment
Time frame: At baseline and 4 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Cramer, MD principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI Brain Scan, Blood draw and Memory testing in people with High Grade Glioma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (336-716-5772, Christina.Cramer@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants to Complete Two PET scans (time frame: At baseline and at 4 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.