[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05576103":3,"trial-entities:NCT05576103":122,"trial-summary:NCT05576103":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":89,"overall_officials":93,"references":94,"see_also_links":121},"NCT05576103","131457","Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients","Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy","RECRUITING","2030-12","2026-06","2026-06-10","2015-01","Jona Hattangadi-Gluth","OTHER",false,"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.","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.\n\nObjective\u002FHypothesis:\n\nThe 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.\n\nSpecific Aims:\n\n1. 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\n2. To identify changes in neurocognitive functioning in primary brain tumor patients after brain radiotherapy\n\nStudy Design:\n\nThe 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.",[19,20,21,22],"Primary Brain Tumor","Glioma","Meningioma","Schwannoma",[],"OBSERVATIONAL",null,[],{"count":28,"type":29},300,"ESTIMATED",[],[32,36,39,42,45,48,51,54,57],{"measure":33,"description":34,"timeFrame":35},"Longitudinal changes in imaging biomarker volume (cc) from volumetric MR imaging","To measure longitudinal changes in volume (cc) from volumetric MR imaging","baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment",{"measure":37,"description":38,"timeFrame":35},"Longitudinal changes in imaging biomarker mean diffusivity (MD) in white matter from DTI imaging","To measure longitudinal changes in MD (mm squared\u002Fsecond) from DTI imaging",{"measure":40,"description":41,"timeFrame":35},"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",{"measure":43,"description":44,"timeFrame":35},"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\n\nScale of scores is:\n\nHopkins 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.\n\nBrief Visuospatial Memory Test-Revised (BVMT-R)- Total, Delayed Recall: l: 0-36 for Immediate, 0-12 for Delayed.\n\nFor both tests, higher scores indicate better performance.",{"measure":46,"description":47,"timeFrame":35},"Change in Executive Functioning after RT","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).\n\nScale of scores is:\n\nControlled 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",{"measure":49,"description":50,"timeFrame":35},"Change in Attention\u002FProcessing Speed after RT","To evaluate the change from baseline to post-RT Attention\u002FProcessing Speed performance when performing fractionated partial brain RT. Attention\u002FProcessing Speed outcomes and measurements include: Trail Making Test Part A (TMT-A)\n\nScale of scores is:\n\nTrail Making Test Part A (TMT-A): 0-240. Higher score indicates poorer performance.",{"measure":52,"description":53,"timeFrame":35},"Change in Language functioning after RT","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\n\nScale of scores is:\n\nBoston Naming Test (BNT): 0-60 Controlled Oral Word Association Test (COWA): category fluency: 0-no upper limit.\n\nFor both tests, higher score indicates better performance.",{"measure":55,"description":56,"timeFrame":35},"Change in Fine Motor Skills after RT","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:\n\nTrail Making Test Motor Speed; Grooved Pegboard Test",{"measure":58,"description":59,"timeFrame":35},"Change in health-related quality of life (hrQoL) from baseline to 5 years after RT","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).\n\nFACT-BR (Functional Assessment of Cancer Therapy - Brain) higher scores on each subscale indicate greater hrQoL.",[],"ALL","18 Years","99 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Patients 18 years or older\n2. Karnofsky performance status (KPS) ≥70\n3. Life expectancy of ≥1 year\n4. Primary brain tumor patients who will receive fractionated partial brain RT\n5. Able to complete neurocognitive assessments\n\nExclusion Criteria:\n\n1. Inability to undergo MRI with contrast\n2. Prior brain RT",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":86},"Moores Cancer Center","San Diego","California","92037","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Lara J Rose","CONTACT","858-822-6575","s4medina@health.ucsd.edu",{"name":85,"role":81},"Jona Hattangadi-Gluth, MD",{"lat":87,"lon":88},32.71571,-117.16472,[90,92],{"name":91,"role":81,"phone":82,"email":83},"Sheila Medina",{"name":85,"role":81},[],[95,99,102,105,108,111,114,117],{"pmid":96,"type":97,"citation":98},"23095829","BACKGROUND","Greene-Schloesser D, Robbins ME. Radiation-induced cognitive impairment--from bench to bedside. Neuro Oncol. 2012 Sep;14 Suppl 4(Suppl 4):iv37-44. doi: 10.1093\u002Fneuonc\u002Fnos196.",{"pmid":100,"type":97,"citation":101},"33412257","Huynh-Le MP, Tibbs MD, Karunamuni R, Salans M, Tringale KR, Yip A, Connor M, Simon AB, Vitzthum LK, Reyes A, Macari AC, Moiseenko V, McDonald CR, Hattangadi-Gluth JA. Microstructural Injury to Corpus Callosum and Intrahemispheric White Matter Tracts Correlate With Attention and Processing Speed Decline After Brain Radiation. Int J Radiat Oncol Biol Phys. 2021 Jun 1;110(2):337-347. doi: 10.1016\u002Fj.ijrobp.2020.12.046. Epub 2021 Jan 4.",{"pmid":103,"type":97,"citation":104},"33543265","Salans M, Tibbs MD, Karunamuni R, Yip A, Huynh-Le MP, Macari AC, Reyes A, Tringale K, McDonald CR, Hattangadi-Gluth JA. Longitudinal change in fine motor skills after brain radiotherapy and in vivo imaging biomarkers associated with decline. Neuro Oncol. 2021 Aug 2;23(8):1393-1403. doi: 10.1093\u002Fneuonc\u002Fnoab017.",{"pmid":106,"type":97,"citation":107},"32712255","Tibbs MD, Huynh-Le MP, Karunamuni R, Reyes A, Macari AC, Tringale KR, Salans M, Yip A, Liu E, Simon A, McDonald CR, Hattangadi-Gluth JA. Microstructural Injury to Left-Sided Perisylvian White Matter Predicts Language Decline After Brain Radiation Therapy. Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1218-1228. doi: 10.1016\u002Fj.ijrobp.2020.07.032. Epub 2020 Jul 23.",{"pmid":109,"type":97,"citation":110},"31408667","Tringale KR, Nguyen TT, Karunamuni R, Seibert T, Huynh-Le MP, Connor M, Moiseenko V, Gorman MK, Marshall A, Tibbs MD, Farid N, Simpson D, Sanghvi P, McDonald CR, Hattangadi-Gluth JA. Quantitative Imaging Biomarkers of Damage to Critical Memory Regions Are Associated With Post-Radiation Therapy Memory Performance in Brain Tumor Patients. Int J Radiat Oncol Biol Phys. 2019 Nov 15;105(4):773-783. doi: 10.1016\u002Fj.ijrobp.2019.08.003. Epub 2019 Aug 10.",{"pmid":112,"type":97,"citation":113},"28068234","Seibert TM, Karunamuni R, Bartsch H, Kaifi S, Krishnan AP, Dalia Y, Burkeen J, Murzin V, Moiseenko V, Kuperman J, White NS, Brewer JB, Farid N, McDonald CR, Hattangadi-Gluth JA. Radiation Dose-Dependent Hippocampal Atrophy Detected With Longitudinal Volumetric Magnetic Resonance Imaging. Int J Radiat Oncol Biol Phys. 2017 Feb 1;97(2):263-269. doi: 10.1016\u002Fj.ijrobp.2016.10.035. Epub 2016 Oct 31.",{"pmid":115,"type":97,"citation":116},"22451194","Meyers CA, Rock EP, Fine HA. Refining endpoints in brain tumor clinical trials. J Neurooncol. 2012 Jun;108(2):227-30. doi: 10.1007\u002Fs11060-012-0813-8. Epub 2012 Mar 27.",{"pmid":118,"type":119,"citation":120},"37150258","DERIVED","Connor M, Salans M, Karunamuni R, Unnikrishnan S, Huynh-Le MP, Tibbs M, Qian A, Reyes A, Stasenko A, McDonald C, Moiseenko V, El-Naqa I, Hattangadi-Gluth JA. Fine Motor Skill Decline After Brain Radiation Therapy-A Multivariate Normal Tissue Complication Probability Study of a Prospective Trial. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):581-593. doi: 10.1016\u002Fj.ijrobp.2023.04.033. Epub 2023 May 6.",[],{"nct_id":4,"conditions":123,"biomarkers":125},[20,21,124,22],"Primary Brain Neoplasm",[],{"nct_id":4,"found":127,"summary":128,"prompt_version":138},true,{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is an observational study that will enroll 300 participants. It is not testing a new treatment, but rather observing changes in patients receiving standard radiation therapy.","completed","Understanding Brain Changes After Radiation for Brain Tumors","This study is looking at how radiation therapy for primary brain tumors (like glioma, meningioma, and schwannoma) affects the brain over time. Researchers will use special MRI scans to measure changes in brain volume and other features, and compare these changes to how your thinking and memory (neurocognition) are affected. The goal is to better understand which parts of the brain are most sensitive to radiation so that future treatments can be designed to protect them. You might be able to join if you are 18 to 99 years old, have a primary brain tumor, and are planning to receive radiation therapy. This is an observational study, meaning researchers will be watching and collecting information, not giving a new treatment. The study aims to enroll 300 participants.","Participants will be followed for 12 months after their radiation treatment.",127,"You would undergo neurocognitive assessments and MRI scans at baseline (before treatment), and then again at 3, 6, and 12 months after treatment.","Not stated in the trial record.",[],"v2"]