MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:April 2005
End Date:December 2014

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This study aims to assess changes in vascular permeability in the brain tumor, and in the
surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).


Inclusion Criteria:

- Patients with a histological confirmed malignancy and presence of intraparenchymal
brain metastases

- Patients are treated by WBRT, SRS, or FSRT

- Age greater than or equal to 18 years

- A life expectancy of greater than or equal to 8 weeks

- Karnofsky performance status (an assessment of general well being and ability to do
activities of daily living; scale ranges from 0 to 100 where 100 is perfect health)
greater than or equal to 60

- Informed consent with signed study-specific informed consent form

Exclusion Criteria:

- Major medical or psychiatric illness, which, in the investigator's opinion, will
prevent completion of the protocol

- Patients with lepto-meningeal metastases documented by Magnetic Resonance Imagine
(MRI), Computed Tomography (CT), or Cerebrospinal Fluid (CSF) evaluation

- For patients that will undergo Whole Brain Radiation Therapy (WBRT), previous WBRT is
not allowed. Patients who have had brain metastases managed by Stereotactic
Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery are
eligible

- For patients that will undergo Stereotactic Radiosurgery (SRS), previous Whole Brain
Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior
Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT),
or surgery is allowed if current treatment will be for a lesion(s) not previously
treated.

- For patients that will undergo Fractionated Stereotactic Radiation Therapy (FSRT),
previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is
not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic
Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a
lesion(s) not previously treated.

- Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker,
implanted cardiac defibrillator, aneurysm clips, etc).

- Patients should have no contraindications to having a contrast enhanced Magnetic
Resonance Imaging (MRI) scan. These contraindications will be assessed at the time of
enrollment using the guidelines set up and in clinical use by the University of
Michigan.

- Women who are pregnant are excluded.
We found this trial at
1
site
Ann Arbor, Michigan 48109
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mi
from
Ann Arbor, MI
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