Detection of Vascular and Neuronal Changes Following Proton and/or Photon Radiotherapy in Patients Receiving Skull Base and/or Brain Radiation
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Neurocognitive evaluation
verbal and visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression
Yes
Michelle Alonso Basanta, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Institutional Review Board
UPCC 08310
NCT01212731
September 2010
September 2013
Name | Location |
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Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |