NCT01212731

Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study

Detection of Vascular and Neuronal Changes Following Proton and/or Photon Radiotherapy in Patients Receiving Skull Base and/or Brain Radiation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * estimate the degree of memory loss, if any following radiotherapy to the base of skull or brain as measured by standard neurocognitive battery testing. * describe radiotherapy dose-related changes in vascular perfusion, in spectroscopic parameters of neuronal injury and changes in the degree and directionality of tissue water diffusivity (diffusion tensor imaging) as a measure of white axonal injury. * to relate these imaging characteristics to the degree of memory loss.

Detailed description

Data suggests that regions of the normal brain exposed to radiation doses that has otherwise been regarded as safe and not limited by current radiation treatment planning may contribute to the risk of late neurocognitive injury. Radiation dose-dependent subclinical vascular effects have been reported in irradiated normal brain tissue and have been hypothesized to be a potential mechanism of action. Direct neuronal injury is another potential mechanism of injury. 1)Estimate the degree of cognitive loss following RT. 2) Demonstrate evidence of radiation induced subclinical vascular and neuronal injury in adjacent brain regions receiving exit doses of radiation. Subjects will include patients with malignancies of the skull of the skull base or patients with low grade glioma who require radiotherapy. Baseline MRI imaging of the brain utilizing established techniques will be used to identify and characterize the regions of interest anatomically adjacent to the regions of intended high dose irradiation. The MRI data for the ROIs will be registered with the radiotherapy treatment planning CT in order to create a single volume of data where each voxel corresponds to a vector containing the multi-parametric information. Subsequent repeat MRI imaging will be at 1.5, 4.5, 12 and 24 months following completion of the radiotherapy for patients with low grade glioma and 1.5 and 12 months post radiotherapy for patients with malignancies involving the skull base. Both cohorts will repeat standard neurocognitive evaluation at 1.5, 4.5,12 and 24 months following completion of radiotherapy. Analysis: Neurocognitive domains will be evaluated at the designated time points.

Conditions

• Malignancy
• Glioma
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Photon treatment plans	10 of the 30 subjects on Cohort 1 will receive photon treatment plans.
RADIATION	Proton Treatment Plans	20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull.
BEHAVIORAL	Neurocognitive evaluation	Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression.
DEVICE	Advanced MRI imaging	Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-08-31
• Completion: 2017-10-17
• First posted: 2010-10-01
• Last updated: 2020-04-08

Locations

1 site across 1 country: United States