RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-02

Study Completion:2033-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04975139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Jiayi Huang, M.D.

CONTACT

314-362-8567

jiayi.huang@wustl.edu

Principal Investigator

Jiayi Huang, M.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Jiayi Huang, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-02

Study Completion Date2033-10-31

Study Record Updates

Study Start Date2020-09-02

Study Completion Date2033-10-31

Terms related to this study

Additional Relevant MeSH Terms

Glioma