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

Status: Completed
Location: See location...
Intervention Type: Radiation, Behavioral, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
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• Study subjects capable of providing informed consent.

• Study subjects with an ECOG performance status of 0-1.

• Study subjects aged 18 or greater.

• Study subjects with a histological diagnosis of a malignancy of the paranasal sinuses or the nasopharynx requiring either definitive or post-operative radiation to a minimum prescribed dose of 60 Gy.

• Study subjects deemed capable of undergoing standard CT simulation and radiotherapy treatment planning and delivery including the capacity to comply with standard immobilization devices to the head and nexk for daily irradiation.

• Study subjects without any evidence of distant metastasis.

• Study subjects with an estimated life expectancy of at least 1 year.

• Study subjects who are able to receive a standard MRI study and deemed capable of complying with the immobilization needs.

• Female study subjects of reproductive potential with a negative pregnancy test prior to each scheduled MRI study.

• Histological confirmed diagnosis of low grade glioma of the CNS

• WHO grade II

• Patients must have a Karnofsky Performance Status of greater than or equal to 60.

• Age greater than or equal to 18.

• Patients must be able to provide informed consent.

• Adequate bone marrow function:WBC greater than or equal to 4000/mm3, platelets greater than or equal to 100,000 mm3.

• Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms, or other barrier methods, etc.). Hysterectomy or meopause must be clinically documented.

• Study subjects deemed capable of undergoing standard CT simulation and radiotherapy treatment planning and delivery including the capacity to comply with standard immobilization devices to the brain for daily irradiation.

Locations
United States
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia
Time Frame
Start Date: September 2010
Completion Date: October 17, 2017
Participants
Target number of participants: 60
Treatments
Cohort 1
Subjects with a histological diagnosis of malignancy of the base of skull necessitating irradiation to a minimum of 60 Gy, ECOG PS 0-1 with no evidence of metastatic disease and an estimate life expectancy of at least 1 year and who is able to provide informed consent. Subjects will undergo standard CT simulation and radiotherapy treatment planning.
Cohort 2
Subjects with a histological diagnosis of low grade glioma requiring radiotherapy. ECOG PS 0-1 with no evidence of metastatic disease and an estimated life expectancy of at least 1 year and who is able to provide informed consent. Subjects will undergo standard CT simulation and radiotherapy treatment planning.
Authors
Michelle Alonso Basanta, Robert Lustig
Sponsors
Collaborators: United States Department of Defense
Leads: Abramson Cancer Center of the University of Pennsylvania

This content was sourced from clinicaltrials.gov

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