A Study of Cognitive Changes in Patients Receiving Brain Radiation

NCT04390906 | Active Not Recruiting

• 1 other identifier: RSRB00070001
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Cranial radiation therapy (RT), commonly used to treat benign and malignant brain tumors, can lead to cognitive impairments in domains not related to neuroanatomic structures directly impacted by the tumor. The study will prospectively enroll 75 patients with benign and low-grade brain tumors who will undergo partial brain RT, with either conventionally fractionated or hypofractionated schedules. Subjects will receive MRI scans at baseline, 6 months, and 12 months. Given the role of the limbic system in key cognitive functions affected by RT, researchers have a particular interest in characterizing MRI changes in the limbic system and thalamus in relation to memory and related processes. Specific Aims:

1. 1.To examine objective neurocognitive changes over time. The investigators hypothesize that they will see RT-induced neurocognitive impairment in up to 50% of patients after cranial RT.
2. 2.To examine changes in brain tissue (via MRI) induced by off-target RT in patients with benign and low-grade brain tumors. The investigators specifically hypothesize that comapping of RT dose and MRI changes in the thalamus and limbic system (i.e., thalamic nuclei, hippocampus, fornix, hypothalamus/mammillary bodies, limbic lobe, cingulum) will be most distorted by off-target RT.
3. 3.To examine the relationship between MRI changes for key neuroanatomic structures identified in Aim 1 with objective neurocognitive testing. The investigators hypothesize that cognitive decline will be correlated with damage revealed by MRI to limbic and thalamic structures.

Conditions

Brain Tumor Adult

Outcome Measures

Primary Outcomes (1)

• Change on HVLT-R delayed recall

  Serial neurocognitive testing using raw scores from the HVLT-R delayed recall

  baseline to 6 months

Secondary Outcomes (5)

• Correlation of change in fractional anisotropy (FA) on diffusion tensor imaging (DTI) in the thalamus and limbic system with RT dose

  baseline to 6 months

• Correlation of change in mean diffusivity (MD) on diffusion tensor imaging (DTI) in the thalamus and limbic system with RT dose

  baseline to 6 months

• Correlation of change on resting state functional MRI (rs-fMRI) and RT dose

  baseline to 6 months

• Correlation of change in region of interest volumes and RT Dose

  baseline to 6 months

• Change in global cognitive function

  baseline to 6 months

Study Arms (1)

All participants

Participants will receive standard of care partial brain radiation therapy at discretion of their radiation oncologist

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 with low grade or benign brain tumors planned to receive partial brain radiation.

You may qualify if:

• \>18 years old patients with brain tumors including low grade gliomas, meningiomas, acoustic neuromas, pituitary adenomas, craniopharyngiomas, hemangiopericytomas, pineal tumors, and other benign or slow-growing brain tumors
• Pathologic diagnosis will be required for gliomas, but not for other tumor types (though it will be recorded if available)
• Within 3 months prior to registration, patients must have a post gadolinium contrast-enhanced three dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2/FLAIR sequence. To yield acceptable image quality with the smallest possible axial slice thickness, , the imaging protocol should include the standard brain tumor protocol sequences: long DTI, sagittal SPGR, and brainlab sequences, resting functional MRI or their equivalent.
• Patients will need to be planned to receive fractionated radiation therapy or stereotactic radiation therapy, either fractionated or single fraction (enrollment must occur prior to radiation therapy so that baseline neurocognitive evaluation can be done)
• Surgical excision and/or chemotherapy treatment prior to enrollment is allowed
• Concurrent chemotherapy with radiation is allowed
• Antiepileptic drugs use, seizures, steroids, anticholinergic medications will be recorded but patients will not be excluded
• Hydrocephalus will be recorded, but patients will not be excluded

You may not qualify if:

• Prior cranial radiation therapy
• Other active malignancy
• Contraindication to MRI imaging such as implanted metal devices or foreign bodies
• Contraindication to gadolinium contrast administration during MR imaging such as allergy or insufficient renal function
• Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per month for the past 2 months
• Life expectancy \<6 months due to other severe comorbidity
• Due to limitations in our ability to test patients in languages other than English, patients will have to be English-speaking
• Diagnosis of pre-existing dementia (clinically significant as defined by a neurologist or other provider), neurodegenerative, or neuro-inflammatory conditions as made by an appropriate health care professional such as a neurologist
• Inability to participate in neuro-cognitive testing
• Significant aphasia leading to difficulty participating in neuro-cognitive testing

Sponsors & Collaborators

• University of Rochester: lead
• Schmitt Program on Integrative Neuroscience: collaborator

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Hardy SJ, Finkelstein AJ, Tivarus M, Culakova E, Mohile N, Weber M, Lin E, Zhong J, Usuki K, Schifitto G, Milano M, Janelsins-Benton MC. Cognitive and neuroimaging outcomes in individuals with benign and low-grade brain tumours receiving radiotherapy: a protocol for a prospective cohort study. BMJ Open. 2023 Feb 15;13(2):e066458. doi: 10.1136/bmjopen-2022-066458.

  PMID: 36792323 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: May 18, 2020
• Study Start: October 16, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)