Cognitive changes in glioma patients after chemoradiotherapy
A Longitudinal Study to Correlate Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks
This study looks at how treatment for brain tumors affects thinking and memory in patients to see if certain brain networks are more at risk after receiving radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT04975139 on ClinicalTrials.gov |
What this trial studies
This observational study investigates neurocognitive decline in glioma patients following chemoradiotherapy, focusing on the impact of radiation dose on resting state networks in the brain. Using resting-state functional MRI (RS-fMRI), the study aims to identify vulnerable neural networks associated with cognitive decline. Patients with IDH-mutant and IDH-wildtype gliomas will undergo neurocognitive evaluations to assess changes in cognitive function post-treatment. The goal is to enhance radiation therapy planning by preserving critical brain networks.
Who should consider this trial
Good fit: Ideal candidates include patients with IDH-mutant or IDH-wildtype gliomas, specifically those with favorable prognostic factors such as younger age or lower-grade tumors.
Not a fit: Patients with non-glioma brain tumors or those with poor prognostic factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes for glioma patients undergoing radiation therapy.
How similar studies have performed: Other studies have shown promising results in preserving cognitive function by avoiding critical neural networks during radiation therapy, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cohort A: histological diagnosis of IDH-mutant astrocytoma or oligodendroglioma, WHO grade II-IV. IDH-mutation may be either by immunohistochemistry (IHC) or next-generation sequencing (NGS) as per routine clinical care. * Cohort B: histological diagnosis of IDH-wildtype astrocytoma, WHO grade II-IV. IDH-wildtype status or absence of IDH-mutation may be either by IHC or NGS as per routine clinical care. The IDH-wildtype patients should have \>80% probability to be alive in 6 months, and the online nomogram calculator below may be used to estimate the 6-month probability: http://cancer4.case.edu/rCalculator/rCalculator.html (Gittleman et al., 2016). The ideal patients are favorable IDH-wildtype astrocytoma patients who are expected to have prolonged survival, such as age ≤ 40 or grade 2-3 tumors. * Cohort C: any non-infiltrative benign brain tumor histology, including but not limited to meningioma, pituitary tumor, schwannoma, craniopharngioma, hemangioblastoma, hemangiopericytoma, pineal tumor, pilocytic astrocytoma, and ganglioglioma. * At least 18 years of age. * Karnofsky performance status (KPS) of at least 70% * Eligible for and planning to receive standard fractionated RT, which can be either photon-based or proton beam therapy. * May be part of other clinical trials and can receive chemotherapy or experimental agents concurrently with or after RT as long as the other clinical trial does not exclude participation in this non-therapeutic study. * Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted). Exclusion Criteria: * Prior cranial RT or RT to the head and neck where potential field overlap may exist * Gliomatosis, leptomeningeal, or metastatic involvement. * Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis). * Require anesthesia to undergo MRI (e.g. severe claustrophobia), which would interfere with RS-fMRI acquisition and processing. * Pregnant or breastfeeding. * Non-English speaking, as the cognitive assessments will only be available in English.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jiayi Huang, M.D. — Washington University School of Medicine
- Study coordinator: Jiayi Huang, M.D.
- Email: jiayi.huang@wustl.edu
- Phone: 314-362-8567
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.