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

Last updated: January 27, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Cancer

Cancer

Cancer/tumors

Treatment

RS-fMRI

Clinical Study ID

NCT04975139
202006111
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohort A: histological diagnosis of IDH-mutant astrocytoma or oligodendroglioma, WHOgrade II-IV. IDH-mutation may be either by immunohistochemistry (IHC) ornext-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 perroutine clinical care. The IDH-wildtype patients should have >80% probability to bealive in 6 months, and the online nomogram calculator below may be used to estimatethe 6-month probability: http://cancer4.case.edu/rCalculator/rCalculator.html (Gittleman et al., 2016). The ideal patients are favorable IDH-wildtype astrocytomapatients who are expected to have prolonged survival, such as age ≤ 40 or grade 2-3tumors.

  • Cohort C: any non-infiltrative benign brain tumor histology, including but notlimited to meningioma, pituitary tumor, schwannoma, craniopharngioma,hemangioblastoma, hemangiopericytoma, pineal tumor, pilocytic astrocytoma, andganglioglioma.

  • 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 eitherphoton-based or proton beam therapy.

  • May be part of other clinical trials and can receive chemotherapy or experimentalagents concurrently with or after RT as long as the other clinical trial does notexclude participation in this non-therapeutic study.

  • Females of childbearing potential (defined as a female who is non-menopausal orsurgically 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 womanbecome pregnant or suspect she is pregnant while participating in this study, shemust inform her treating physician immediately.

  • Able to understand and willing to sign an IRB-approved written informed consentdocument (legally authorized representative permitted).

Exclusion

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-stagekidney disease or on hemodialysis).

  • Require anesthesia to undergo MRI (e.g. severe claustrophobia), which wouldinterfere with RS-fMRI acquisition and processing.

  • Pregnant or breastfeeding.

  • Non-English speaking, as the cognitive assessments will only be available inEnglish.

Study Design

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: RS-fMRI
Phase:
Study Start date:
September 02, 2020
Estimated Completion Date:
October 31, 2033

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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