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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975139
• Other study ID #: 202006111
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: October 31, 2033

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: Jiayi Huang, M.D.
• Phone: 314-362-8567
• Email: jiayi.huang[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 31, 2033
• Est. primary completion date: October 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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). 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).

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Device:
• RS-fMRI
Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in patient reported outcomes as measured by the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)	-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.	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	Change in quality of life as measured by the Linear Analog Scale Assessment (LASA)	-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).	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	Tumor progression		Through completion of follow-up (estimated to be 10 years and 2 months)
Secondary	Overall survival		Through completion of follow-up (estimated to be 10 years and 2 months)

External Links

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