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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05087888
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Caroline Chung
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Neoplasm
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Procedure: - Biospecimen Collection

Undergo collection of blood samples

Procedure: - Magnetic Resonance Imaging

Undergo functional MRI

Procedure: - Multiparametric Magnetic Resonance Imaging

Undergo multiparametric MRI

Other: - Questionnaire Administration

Complete questionnaires

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston 4699066, Texas 4736286

Status

Address

M D Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

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