NCT05576103 · Jona Hattangadi-Gluth
Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients
What this study is about
In this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain.
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In this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain. Quantitative neuroimaging, radiation dose information, and directed neurocognitive testing will be acquired through this study to improve understanding of cognitive changes associated with radiation dosage to non-targeted tissue, and will provide the basis for evidence-based cognitive- sparing brain radiotherapy.
Primary outcome measures
Longitudinal changes in imaging biomarker volume (cc) from volumetric MR imaging
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To measure longitudinal changes in volume (cc) from volumetric MR imaging
Longitudinal changes in imaging biomarker mean diffusivity (MD) in white matter from DTI imaging
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To measure longitudinal changes in MD (mm squared/second) from DTI imaging
Longitudinal changes in imaging biomarker fractional anisotropy (FA) in white matter from DTI imaging
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To measure longitudinal changes in FA (unitless index between 0 and 1) from DTI imaging
Change in Memory after RT
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To evaluate the change from baseline to post-RT verbal memory performance when performing fractionated partial brain RT. Verbal memory outcomes and measurements include: Hopkins Verbal Learning Test-Revised (HVLT-R)-Immediate, Delayed Recall. Brief Visuospatial Memory Test-Revised (BVMT-R)- Total, Delayed Recall Scale of scores is: Hopkins Verbal Learning Test-Revised (HVLT-R)-Immediate, Delayed Recall: 0-36 for Immediate, 0-12 for Delayed. For both tests, higher scores indicate better performance. Brief Visuospatial Memory Test-Revised (BVMT-R)- Total, Delayed Recall: l: 0-36 for Immediate, 0-12 for Delayed. For both tests, higher scores indicate better performance.
Change in Executive Functioning after RT
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To evaluate the change from baseline to post-RT executive functioning performance when performing fractionated partial brain RT. Executive functioning outcomes and measurements include: Controlled Oral Word Association Test (COWA): letter fluency, Trail Making Test Part B (TMT-B). Scale of scores is: Controlled Oral Word Association Test (COWA): letter fluency: 0- no upper limit. Higher score indicates better performance Trail Making Test Part B (TMT-B): 0-240. Higher score indicates poorer performance
Change in Attention/Processing Speed after RT
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To evaluate the change from baseline to post-RT Attention/Processing Speed performance when performing fractionated partial brain RT. Attention/Processing Speed outcomes and measurements include: Trail Making Test Part A (TMT-A) Scale of scores is: Trail Making Test Part A (TMT-A): 0-240. Higher score indicates poorer performance.
Change in Language functioning after RT
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To evaluate the change from baseline to post-RT Language performance when performing fractionated partial brain RT in patients with primary brain tumor. Language outcomes and measurements include: Boston Naming Test (BNT), Controlled Oral Word Association Test (COWA): category fluency Scale of scores is: Boston Naming Test (BNT): 0-60 Controlled Oral Word Association Test (COWA): category fluency: 0-no upper limit. For both tests, higher score indicates better performance.
Change in Fine Motor Skills after RT
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To evaluate the change from baseline to post-RT Fine Motor Skills performance when performing fractionated partial brain RT in patients with primary brain tumor. Fine Motor Skills outcomes and measurements include: Trail Making Test Motor Speed; Grooved Pegboard Test
Change in health-related quality of life (hrQoL) from baseline to 5 years after RT
Time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
To evaluate the change from baseline to post-RT health-related quality of life (hrQoL) when performing fractionated partial brain RT in patients with primary brain tumor. Quality of life outcomes and measurements include: Beck Depression inventory II (BDI II), Beck Anxiety Inventory (BAI) and FACT-BR (Functional Assessment of Cancer Therapy - Brain). FACT-BR (Functional Assessment of Cancer Therapy - Brain) higher scores on each subscale indicate greater hrQoL.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients 18 years or older
- Karnofsky performance status (KPS) ≥70
- Life expectancy of ≥1 year
- Primary brain tumor patients who will receive fractionated partial brain RT
- Able to complete neurocognitive assessments
Exclusion criteria
- Inability to undergo MRI with contrast
- Prior brain RT
Where
- San Diego, California
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Frequently asked questions
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations