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


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignancy, Glioma, Radiotherapy

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Trial Information

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.


Inclusion Criteria:

For Cohort 1 (Patients with tumor involving the base of skull)

- 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.

Inclusion Criteria:

For Cohort 2 (Patients with Low Grade Gliomas)

- 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.

Exclusion Criteria: for Both Cohorts

- Study subjects with questionable performance status and in whom the treating
physician is suspicious that a life expectancy of at least 1 year is possible.

- Study subjects with anxiety that precludes the safe administration of a MRI for the
imaging time required.

- Study subjects with major psychiatric diagnosis prior to neuro-oncologic diagnosis.

- For neuropsychological studies, study subjects with neurological or behavioral issues
that would preclude compliance with study procedures. (Karnofsky Performance Scale
score of less than 60, indicating that the patients needs considerable assistance for
self care and frequent medical care).

- Study subjects with an inability to undergo MR Imaging for any reason.

- Study subjects with a history of renal transplant or known renal disorder with a
calculated GFR > 45mL/1min [gadolinium restriction]

- For neuropsychological studies, study subjects with mixed language background with
only one year of educationin an English-speaking school.

- Pregnant women, women planning to become pregnant and women who are nursing.

Additional Exclusion Criteria for Cohort 2 (Patients with Low Grade Gliomas)

- Prior or simultaneous malignancies within the past two years (other than cutaneous
squamos or basal cell carcinoma, melanoma in situ or well differentiated thyroid
carcinoma).

- Patients with the following histologies are excluded: Gliomatosis cerebri, WHO III or
IV gliomas.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Neurocognitive evaluation

Outcome Description:

verbal and visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression

Safety Issue:

Yes

Principal Investigator

Michelle Alonso Basanta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 08310

NCT ID:

NCT01212731

Start Date:

September 2010

Completion Date:

September 2013

Related Keywords:

  • Malignancy
  • Glioma
  • Radiotherapy
  • Patients with malignancies of the skull base or patients with low grade glioma who require radiotherapy.
  • Neoplasms
  • Glioma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283