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NCT Number: NCT05576103

Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients

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.

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Key information

Conditions

Primary Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neuroma Schwannoma

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moores Cancer Center

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Jona Hattangadi-Gluth, MD

CONTACT

Lara J Rose

CONTACT

[email protected]

858-822-6575

About this study

Background: Fractionated radiation therapy (RT) is a mainstay in the treatment of primary and metastatic brain tumors. However, RT to the brain is associated with an inevitable decline in neurocognitive function in up to 90% of patients who survive more than 6 months after irradiation. Radiation to the brain results in an inevitable decline in neurocognitive function, mediated by tissue injury to white matter, cortex and subcortical areas. With quantitative magnetic resonance imaging (MRI) techniques, investigators can directly and non-invasively measure such changes.

Objective/Hypothesis:

The purpose of this study is to examine radiation-induced imaging changes in normal brain tissue over time in primary brain tumor patients, and correlate these with neurocognitive outcomes. The overarching goal is to better identify sensitive brain regions so that future radiation techniques can be optimally designed to mitigate collateral damage.

Specific Aims:

  • To identify microstructural changes in subcortical white matter, hippocampus, and cortex associated with quantified regional exposure to fractionated brain radiotherapy using advanced quantitative neuroimaging imaging
  • To identify changes in neurocognitive functioning in primary brain tumor patients after brain radiotherapy

Study Design:

The investigators will prospectively enroll primary brain tumor patients undergoing fractionated partial brain radiation therapy. Patients will undergo volumetric and diffusion brain MRI (per clinical standard-of-care) and a neurocognitive battery of tests at baseline (pre-treatment), 3 months, 6 months, and 12 months post-treatment. Clinical data including age, gender, educational status, tumor size and histology, steroid use, antiepileptic drug use and chemotherapy will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jona Hattangadi-Gluth, MD

CONTACT

Sheila Medina

CONTACT

[email protected]

858-822-6575

Sponsors and collaborators

Lead sponsor

Jona Hattangadi-Gluth

Other

Registry information

Official study title

Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Oct 12, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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