Recruiting

Observational Study

Sponsor:

Jona Hattangadi-Gluth

Code:

NCT05576103

Conditions

Primary Brain Tumor

Glioma

Meningioma

Schwannoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05576103

Start date

Jan, 2015

Status verified date

Jun, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients 18 years or older
2. Karnofsky performance status (KPS) ≥70
3. Life expectancy of ≥1 year
4. Primary brain tumor patients who will receive fractionated partial brain RT
5. Able to complete neurocognitive assessments

Exclusion Criteria:

1. Inability to undergo MRI with contrast
2. Prior brain RT

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 ]
  • 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 ]
  • 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 ]
  • Change in Memory after RT [ Time Frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment ]
  • Change in Executive Functioning after RT [ Time Frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment ]
  • Change in Attention/Processing Speed after RT [ Time Frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment ]
  • Change in Language functioning after RT [ Time Frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment ]
  • Change in Fine Motor Skills after RT [ Time Frame: 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 [ Time Frame: baseline (pre-treatment), 3 months, 6 months, 12 months post-treatment ]

Central Contacts and Locations

Central contacts

Sheila Medina

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

Locations

Moores Cancer Center

Recruiting

San Diego, California, United States, 92037

Contacts

Lara J Rose

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

More Information

Sponsor

Jona Hattangadi-Gluth

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jona Hattangadi-Gluth on 2026-06-10.