Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorJona Hattangadi-Gluth
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to undergo MRI with contrast
Prior brain RT
Trial population
Primary brain tumor patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Primary brain tumour patients receiving RT
Trial outcomes
Primary outcomes
1
Longitudinal changes in imaging biomarker volume (cc) from volumetric MR imaging
To measure longitudinal changes in volume (cc) from volumetric MR imaging
Time frame
baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment2
Longitudinal changes in imaging biomarker mean diffusivity (MD) in white matter from DTI imaging
To measure longitudinal changes in MD (mm squared/second) from DTI imaging
Time frame
baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment3
Longitudinal changes in imaging biomarker fractional anisotropy (FA) in white matter from DTI imaging
To measure longitudinal changes in FA (unitless index between 0 and 1) from DTI imaging
Time frame
baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment4
Change in Memory after RT
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.
Time frame
baseline (pre-treatment), 3 months, 6 months, 12 months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jona Hattangadi-Gluth
Lead sponsor
University of California, San Diego
Sponsor institution
Source ClinicalTrials.gov