MRI and Blood Biomarkers for the Prediction of Neurocognitive Decline Following Brain Radiation

April 17, 2026 updated by: M.D. Anderson Cancer Center

Investigation of Serial Advanced Magnetic Resonance Imaging (MRI) and Biofluid Biomarkers Predictive of Neurocognitive Decline Following Brain Radiation

This study determines whether non-invasive evaluation using repeated magnetic resonance imaging (MRI) scans and repeated blood biomarker measurements can be used to predict changes in a person's mental functions that result from radiation exposure to the brain. This study may let researchers monitor patient responses to treatment and the disease better and possibly make changes to patient treatment, if needed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To describe changes of image features on conventional T1- and T2- weighted imaging, and quantitative changes on multiparametric MRI including apparent diffusion coefficient (ADC), fractional anisotropy (FA), relative cerebral blood volume (rCBV), fractional volume of the extravascular, extracellular space (ve) and Ktrans (transfer constant that characterizes the diffusive transport of low-molecular weight gadolinium across the capillary endothelium) associated with neurocognitive changes following radiation.

SECONDARY OBJECTIVES:

I. To identify biofluid biomarkers at baseline and dynamics of biomarkers after radiation exposure that are associated with neurocognitive changes.

II. To model a composite early biomarker (baseline or within 3 weeks of the start of radiotherapy) that incorporates the most promising imaging and biofluid biomarkers to predict for later neurocognitive decline.

III. To evaluate the relationship between the delivered radiation dosimetry to brain subregions and patterns of neurocognitive decline in order to inform potential subregions of focus for future pre-clinical and clinical investigation.

IV. To evaluate the relationship between quantitative changes on multiparametric MRI including apparent diffusion coefficient (ADC), fractional anisotropy (FA), relative cerebral blood volume (rCBV), fractional volume of the extravascular, extracellular space (ve) and Ktrans (transfer constant that characterizes the diffusive transport of low-molecular weight gadolinium across the capillary endothelium) with radiation dosimetry.

EXPLORATORY OBJECTIVE:

I. To explore changes on advanced MR measurements of structural connectomics, functional connectomics, working memory network, cerebrovascular reactivity (CVR), cerebral blood flow (CBF) and brain metabolism associated with neurocognitive changes following radiation.

OUTLINE:

Patients undergo multiparametric MRI with contrast at baseline, 3 weeks during radiotherapy, and at 1, 3, 6, 12, and 24 months post-radiotherapy. Patients undergo multiparametric MRI without contrast at 1, 2, 4, 5, and 6 weeks during radiotherapy. Patients may undergo functional MRI at baseline and 6 months post-radiotherapy. Patients also complete questionnaires and undergo collection of blood samples at baseline, weekly through week 6 during radiotherapy, and at 1, 3, 6, 12, and 24 months post radiotherapy.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing central nervous system (CNS) or head and neck (H&N) radiotherapy with radiation exposure to the brain to investigate the pattern of neurocognitive changes in relation to brain dosimetry and associated imaging and biofluid biomarkers predictive of neurocognitive outcomes

Description

Inclusion Criteria:

  • Patients must be age >= 18 years
  • Patients must be planned for fractionated radiotherapy that will be delivered over at least 5 weeks and that will expose the brain to radiation
  • Patients must have Karnofsky performance status (KPS) >= 80
  • Patients must be able to obtain an MRI scan with gadolinium contrast
  • Female patients of childbearing age must not be pregnant as determined with a serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy). Pregnancy tests are part of standard of care routine if a patient is receiving radiation treatment
  • Patient must be fluent enough in English to complete neurocognitive testing
  • Education of >= 12 years (high school graduate or equivalent) by patient self-report
  • Patient is able to complete an in-person and electronic neurocognitive assessments (i.e. is alert and has the ability to comprehend and complete the assessments)
  • Patient has no history of psychiatric or medical conditions that would result in an inability to complete serial neurocognitive tests, severe claustrophobia, prior cerebrovascular event(s), degenerative neurological diagnoses (e.g., dementia, Parkinson's, multiple sclerosis [MS]) or severe psychiatric illness (e.g., schizophrenia) that may impact neurocognitive and imaging assessments

Exclusion Criteria:

  • Previous brain radiation without comprehensive dosimetry records
  • Concurrent chemotherapy
  • Psychiatric or medical conditions that would result in inability to complete serial neurocognitive tests
  • Severe claustrophobia requiring sedative medications for the MRI
  • Prior cerebrovascular event(s) or degenerative neurological diagnoses (e.g., dementia, Parkinson's, MS)
  • Contraindication to gadolinium-based contrast administration for MRI (i.e. allergy to gadolinium or severe chronic kidney disease defined by estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2, as per institutional policy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (MRI, questionnaire, blood collection)
Patients undergo multiparametric MRI with contrast at baseline, 3 weeks during radiotherapy, and at 1, 3, 6, 12, and 24 months post-radiotherapy. Patients undergo multiparametric MRI without contrast at 1, 2, 4, 5, and 6 weeks during radiotherapy. Patients may undergo functional MRI at baseline and 6 months post-radiotherapy. Patients also complete questionnaires and undergo collection of blood samples at baseline, weekly through week 6 during radiotherapy, and at 1, 3, 6, 12, and 24 months post radiotherapy.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
Other: Questionnaire Administration
Complete questionnaires
Procedure: Magnetic Resonance Imaging
Undergo functional MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Multiparametric Magnetic Resonance Imaging
Undergo multiparametric MRI
Other Names:
  • Multiparametric MRI
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To describe changes of image features on conventional T1- and T2- weighted imaging, and quantitative changes on the multipara metric MRI.
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Caroline Chung, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

August 22, 2019

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA18-0719 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-09725 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Neoplasm

Clinical Trials on Biospecimen Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe