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

NCT04975139 | Recruiting DMC FDA Device

• 1 other identifier: 202006111
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Change in neurocognitive scores as measured by NIH Toolbox cognitive battery tests

  -The National Institutes of Health (NIH) has developed the National Institutes of Health Toolbox for the Assessment of Neurological and Behavior Function (NIHTB), which is a validated, normed, and multidimensional set of brief measures to assess cognitive, emotional, motor, and sensory function. The NIHTB cognitive battery (NIHTB-CB) consists of 10 tasks and can be administered in 40 min. The scores can be evaluated separately, or they can be combined into composite scores: crystallized cognition composite (reflecting the ability to access information from long-term memory and general knowledge), fluid cognition composite (reflecting the processing ability to adapt to novel environment and solve problems), and overall cognitive function composite (a combination of both crystallized and fluid scores).

  Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, 2 years after completion of radiation therapy, 5 years after completion of radiation therapy, and 10 years after completion (estimated to be 10 years and 2 months)

Secondary Outcomes (4)

• Change in patient reported outcomes as measured by the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

  Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, 2 years after completion of radiation therapy, 5 years after completion of radiation therapy, and 10 years after completion (estimated to be 10 years and 2 months)

• Change in quality of life as measured by the Linear Analog Scale Assessment (LASA)

  Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, 2 years after completion of radiation therapy, 5 years after completion of radiation therapy, and 10 years after completion (estimated to be 10 years and 2 months)

• Tumor progression

  Through completion of follow-up (estimated to be 10 years and 2 months)

• Overall survival

  Through completion of follow-up (estimated to be 10 years and 2 months)

Study Arms (3)

IDH-mutant astrocytoma or oligodendroglioma

After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed.

Device: RS-fMRI

IDH-wildtype astrocytoma

After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed.

Device: RS-fMRI

Benign Brain Tumor

After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed.

Device: RS-fMRI

Interventions

RS-fMRI DEVICE

Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain

Also known as: Resting-state functional MRI

Benign Brain Tumor; IDH-mutant astrocytoma or oligodendroglioma; IDH-wildtype astrocytoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Siteman Cancer Center at Washington University School of Medicine.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jiayi Huang, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayi Huang, M.D.

CONTACT

314-362-8567; jiayi.huang@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: September 2, 2020
• Primary Completion (Estimated): October 31, 2033
• Study Completion (Estimated): October 31, 2033
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)