Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients

NCT05576103 | Recruiting

• 1 other identifier: 131457
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Brain Tumor; Glioma; Meningioma; Schwannoma

Outcome Measures

Primary Outcomes (9)

• 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

• 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

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• 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

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• 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.

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• 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). 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

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• Change in Attention/Processing Speed after RT

  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.

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• 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 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.

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• 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: Trail Making Test Motor Speed; Grooved Pegboard Test

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

• 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). FACT-BR (Functional Assessment of Cancer Therapy - Brain) higher scores on each subscale indicate greater hrQoL.

  baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment

Study Arms (1)

Primary brain tumour patients receiving RT

Primary brain tumor patients are screened at time of consultation for this observational study, and the study population is diverse across sex/gender, and racial/ethnic groups.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary brain tumor patients

You may qualify if:

• 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

You may not qualify if:

• Inability to undergo MRI with contrast
• Prior brain RT

Sponsors & Collaborators

• Jona Hattangadi-Gluth: lead

Study Sites (1)

Moores Cancer Center

San Diego, California, 92037, United States

RECRUITING

Related Publications (8)

• 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/neuonc/nos196.

  PMID: 23095829 BACKGROUND

• 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/j.ijrobp.2020.12.046. Epub 2021 Jan 4.

  PMID: 33412257 BACKGROUND

• 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/neuonc/noab017.

  PMID: 33543265 BACKGROUND

• 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/j.ijrobp.2020.07.032. Epub 2020 Jul 23.

  PMID: 32712255 BACKGROUND

• 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/j.ijrobp.2019.08.003. Epub 2019 Aug 10.

  PMID: 31408667 BACKGROUND

• 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/j.ijrobp.2016.10.035. Epub 2016 Oct 31.

  PMID: 28068234 BACKGROUND

• Meyers CA, Rock EP, Fine HA. Refining endpoints in brain tumor clinical trials. J Neurooncol. 2012 Jun;108(2):227-30. doi: 10.1007/s11060-012-0813-8. Epub 2012 Mar 27.

  PMID: 22451194 BACKGROUND

• 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/j.ijrobp.2023.04.033. Epub 2023 May 6.

  PMID: 37150258 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Meningioma; Neurilemmoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neuroendocrine Tumors; Neuroma; Nerve Sheath Neoplasms

Central Study Contacts

Sheila Medina

CONTACT

858-822-6575; s4medina@health.ucsd.edu

Jona Hattangadi-Gluth, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)