Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks

  • STATUS
    Recruiting
  • End date
    Nov 30, 2028
  • participants needed
    44
  • sponsor
    Washington University School of Medicine
Updated on 29 July 2021
karnofsky performance status
immunohistochemistry
astrocytoma
brain tumor
oligodendroglioma
ganglioglioma

Summary

Neurocognitive decline after radiation therapy is one of the most concerning complication for brain tumor patients and neuro-oncologists. There are increasing technological advances in evaluating the brain's neural connections responsible for the neurocognitive processes. For example, resting-state functional MRI (RS-fMRI) is an advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain (also referred to as resting state networks (RSNs) without requiring specific tasks by the imaged participants. Although there is evidence that shows that avoidance of specific neural networks during radiation therapy planning can lead to improved preservation of neurocognitive function afterward, it is important to first identify the most vulnerable and clinically relevant RSNs that correspond to cognitive decline. In this study, the investigators will prospectively perform RS-fMRI and neurocognitive evaluation using the NIH Toolbox Cognitive Battery (NIHTB-CB) on patients with gliomas before and after radiation therapy to generate preliminary data on what RSNs are most vulnerable to radiation injury leading to cognitive decline. A benign brain tumor cohort will also be followed to serve as control. The investigators will also evaluate the feasibility of incorporating RS-fMRI with radiation planning software for treatment optimization.

Details
Condition Glioma, Gliomas, glial tumor
Treatment RS-fMRI
Clinical Study IdentifierNCT04975139
SponsorWashington University School of Medicine
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

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)
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
The tumor should be in the supratentorium, excluding brainstem and cerebellum
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
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