Evaluating cognitive function after targeted 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
NA · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · NCT03223922
This study is testing a new type of brain radiation therapy to see if it can help people with brain metastases keep their thinking skills while still treating their cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (other) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT03223922 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of genu-sparing whole brain radiation therapy (WBRT) on cognitive and neuropsychiatric functioning in patients with brain metastases. The study aims to prevent radiation-induced cognitive decline by limiting radiation exposure to sensitive brain structures, particularly the genu of the corpus callosum. Participants must have a confirmed solid tumor malignancy and be scheduled for WBRT, with eligibility criteria ensuring they have adequate cognitive function and performance status. The study seeks to determine if this innovative approach can preserve cognitive abilities without compromising tumor control.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed solid tumor malignancy and scheduled for whole brain radiation therapy.
Not a fit: Patients with metastases to the genu of the corpus callosum or those with a Karnofsky Performance Status below 70 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive outcomes and quality of life for patients undergoing treatment for brain metastases.
How similar studies have performed: While other studies have explored hippocampal avoidance in WBRT, this specific approach targeting the genu of the corpus callosum is novel and has not been previously evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- The SKCCC at Johns Hopkins — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Kristin Redmond, MD, MPH — The SKCCC at Johns Hopkins
- Study coordinator: Kristin Redmond, MD
- Email: kjanson3@jhmi.edu
- Phone: 410-614-1642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, whole brain radiation therapy, genu of corpus callosum, cognitive function