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

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ClinicalTrials.gov Identifier: NCT05087888
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Brain Neoplasm Procedure: Biospecimen Collection Procedure: Magnetic Resonance Imaging Procedure: Multiparametric Magnetic Resonance Imaging Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Serial Advanced Magnetic Resonance Imaging (MRI) and Biofluid Biomarkers Predictive of Neurocognitive Decline Following Brain Radiation
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: Biological Sample Collection

Procedure: Magnetic Resonance Imaging
Undergo functional MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Multiparametric Magnetic Resonance Imaging
Undergo multiparametric MRI
Other Names:
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI
  • Multiparametric MRI

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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:

  • Prior radiation to the brain
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087888


Contacts
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Contact: Caroline Chung 713-563-2300 cchung3@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Caroline Chung    713-563-2300    cchung3@mdanderson.org   
Principal Investigator: Caroline Chung         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Caroline Chung M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05087888    
Other Study ID Numbers: PA18-0719
NCI-2021-09725 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA18-0719 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases