Clinical trial · Interventional
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study
NCT03223922CI-TRIAL-00116362active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a trial that evaluates the preservation of cognition and neuropsychiatric function following genu-sparing whole brain radiation in patients with brain metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| whole brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy
- description
- Genu-sparing whole brain radiation therapy (GS-WBRT) 30 Gy in 3 Gy per fraction
- interventionNames
- Radiation: whole brain radiation therapy
Primary outcomes (1)
- measure
- Rate of change of cognitive function
- timeFrame
- 4 months
- description
- Evaluate changes in cognition from baseline to 4 months following genu-sparing whole brain radiation therapy (GS-WBRT)
Secondary outcomes (5)
- measure
- Rate of change of white matter microstructure
- timeFrame
- 4, 6 and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof or unequivocal cytologic proof solid tumor malignancy. This may be obtained from either the primary or any metastatic site * Mini Mental State Examination (MMSE) ≥24 * Age≥ 18 years * Karnofsky Performance Status (KPS) ≥70 * Patient does not have metastases to the genu * Patient must be scheduled to undergo treatment with whole brain radiation therapy (WBRT) to manage the brain metastases * Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child * Patient must have the ability to understand and the willingness to sign a written informed consent document * All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines * Patient must have a minimal life expectancy of at least 6 months * Patients receiving prior stereostatic radiosurgery (SRS) for brain metastases are eligible Exclusion Criteria: * Prior WBRT * MMSE\<24 * Patient has brain metastases in the genu * Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits. * KPS\<70 * Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks. * Patients with absolute contraindication to MRI imaging are not eligible for the study
References
Publications (0)
Data not yet available
No reference posted for this study.