Primary Brain TumorNCT05576103
Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients
An observational study of Primary Brain Tumor and Glioma, run by Jona Hattangadi-Gluth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary Brain Tumor, Glioma, Meningioma
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary brain tumor patients
Who may be able to join
- 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
Who cannot join
- Inability to undergo MRI with contrast
- Prior brain RT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jona Hattangadi-Gluth, MD contact
United States1 site, 1 recruiting
- Recruiting
Moores Cancer Center
San Diego, California, 92037
Lara J Rose, 858-822-6575, s4medina@health.ucsd.edu
Jona Hattangadi-Gluth, MD
About this study
Official title: Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy
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.
Read the detailed description
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.
- Conditions
- Primary Brain Tumor, Glioma, Meningioma, Schwannoma
- Medical subject headings
- Brain Neoplasms, Glioma, Meningioma, Neurilemmoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal changes in imaging biomarker volume (cc) from volumetric MR imaging
To measure longitudinal changes in volume (cc) from volumetric MR imaging
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study startJan 2015
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jona Hattangadi-Gluth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jona Hattangadi-Gluth, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576103
- Sponsor's protocol ID
- 131457
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23095829Huynh-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.
PubMed 33412257Salans 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.
PubMed 33543265Tibbs 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.
PubMed 32712255Tringale 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.
PubMed 31408667Seibert 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.
PubMed 28068234Meyers 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.
PubMed 22451194Connor 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.
PubMed 37150258
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT05576103
- Acronym / sponsor ID
- 131457
- Conditions
- Primary Brain Tumor, Glioma, Meningioma, Schwannoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jona Hattangadi-GluthUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary brain tumor patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to undergo MRI with contrast
- Prior brain RT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 23095829Greene-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.
- Background: PubMed 33412257Huynh-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.
- Background: PubMed 33543265Salans 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.
- Background: PubMed 32712255Tibbs 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.
- Background: PubMed 31408667Tringale 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.
- Background: PubMed 28068234Seibert 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.
- Background: PubMed 22451194Meyers 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.
- Derived from this study: PubMed 37150258Connor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jona Hattangadi-Gluth, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brain Tumor and Glioma, run by Jona Hattangadi-Gluth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheila Medina (858-822-6575, s4medina@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal changes in imaging biomarker volume (cc) from volumetric MR imaging (time frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576103, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.