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

NCT05087888 | Terminated

• 2 other identifiers: PA18-0719NCI-2021-09725
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• To describe changes of image features on conventional T1- and T2- weighted imaging, and quantitative changes on the multipara metric MRI.

  Up to 24 months

Study Arms (1)

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; Procedure: Magnetic Resonance Imaging; Procedure: Multiparametric Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection

Observational (MRI, questionnaire, blood collection)

Magnetic Resonance Imaging PROCEDURE

Undergo functional MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Observational (MRI, questionnaire, blood collection)

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo multiparametric MRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Observational (MRI, questionnaire, blood collection)

Questionnaire Administration OTHER

Complete questionnaires

Observational (MRI, questionnaire, blood collection)

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 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Caroline Chung

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 21, 2021
• Study Start: August 22, 2019
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)