MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
NCT ID: NCT02031237
Last Updated: 2019-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
52 participants
OBSERVATIONAL
2005-04-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stereotactic Radiosurgery (SRS)
Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.
MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series.
Single Fraction Stereotactic Radiosurgery (SRS)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Whole Brain Radiation Therapy
Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.
MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.
Fractionated Whole Brain Radiation Therapy (WBRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Stereotactic Radiation Therapy
Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.
MRI scans will be performed approximately 1-2 weeks prior to FSRT, during the last week of RT but before the last fraction and 1 month after RT. The MRI scan will include a routine clinical MRI series.
Fractionated Stereotactic Radiation Therapy (FSRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Interventions
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Single Fraction Stereotactic Radiosurgery (SRS)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Fractionated Whole Brain Radiation Therapy (WBRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Fractionated Stereotactic Radiation Therapy (FSRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yue Cao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00043426
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2005.003
Identifier Type: -
Identifier Source: org_study_id
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