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

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ClinicalTrials.gov Identifier: NCT04975139
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : July 23, 2021
Sponsor:
Collaborator:
The Foundation for Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Glioma Device: RS-fMRI

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Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study to Correlate Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IDH-mutant Glioma
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 and 24 months from the completion of RT (+/- 3 months), a second and third RS-fMRI will be performed.
Device: RS-fMRI
Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain
Other Name: Resting-state functional MRI

IDH-wildtype Glioma
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 and 24 months from the completion of RT (+/- 3 months), a second and third RS-fMRI will be performed.
Device: RS-fMRI
Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain
Other Name: Resting-state functional MRI

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 and 24 months from the completion of RT (+/- 3 months), a second and third RS-fMRI will be performed.
Device: RS-fMRI
Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain
Other Name: Resting-state functional MRI




Primary Outcome Measures :
  1. Change in neurocognitive scores as measured by NIH Toolbox cognitive battery tests [ Time Frame: Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, and 24 months after completion of radiation therapy (estimated to be 2 years and 2 months) ]
    -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).


Secondary Outcome Measures :
  1. Change in patient reported outcomes as measured by the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) [ Time Frame: Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, and 24 months after completion of radiation therapy (estimated to be 2 years and 2 months) ]
    -The MDASI-BT is one of the most commonly used brain-specific patient-reported questionnaires on symptom burden and has been validated extensively in the adult glioma population. It can be completed in 5 minutes and allows self-reporting of symptom severity and interference with daily activities. 22 questions asking how severe are the symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions asking how the symptoms have interfered with life with answers ranging from0=did not interfere to 10=interfered completely.

  2. Change in quality of life as measured by the Linear Analog Scale Assessment (LASA) [ Time Frame: Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, and 24 months after completion of radiation therapy (estimated to be 2 years and 2 months) ]
    -Linear Analog Scale Assessment (LASA) is a single-item questionnaire that asks the patients to rate their overall quality of life (QOL). The LASA scale runs from 0 (as bad as it can be) to 10 (as good as it can be).

  3. Tumor progression [ Time Frame: Through completion of follow-up (estimated to be 5 years) ]
  4. Overall survival [ Time Frame: Through completion of follow-up (estimated to be 5 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at Siteman Cancer Center at Washington University School of Medicine.
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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975139


Contacts
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Contact: Jiayi Huang, M.D. 314-362-8567 jiayi.huang@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jiayi Huang, M.D.    314-362-8567    jiayi.huang@wustl.edu   
Principal Investigator: Jiayi Huang, M.D.         
Sub-Investigator: Stephanie Perkins, M.D.         
Sub-Investigator: Joshua Shimony, M.D., Ph.D.         
Sub-Investigator: Abraham Z Snyder, M.D., Ph.D.         
Sub-Investigator: Tim Mitchell, Ph.D.         
Sub-Investigator: Yi Huang, M.S.         
Sub-Investigator: Chris Abraham, M.D.         
Sub-Investigator: Jian Campian, M.D., Ph.D.         
Sub-Investigator: Milan Chheda, M.D.         
Sub-Investigator: Tanner Johanns, M.D., Ph.D.         
Sub-Investigator: Benjamin Seitzman, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
The Foundation for Barnes-Jewish Hospital
Investigators
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Principal Investigator: Jiayi Huang, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04975139    
Other Study ID Numbers: 202006111
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue