Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02031237 : MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02031237      |      Link to official Clinicaltrials.gov listing
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