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

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ClinicalTrials.gov Identifier: NCT02031237
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Single Fraction Stereotactic Radiosurgery (SRS) Radiation: Fractionated Whole Brain Radiation Therapy (WBRT) Radiation: Fractionated Stereotactic Radiation Therapy (FSRT) Device: Magnetic Resonance Imaging (MRI) Assessments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
Study Start Date : April 2005
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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.

Radiation: Single Fraction Stereotactic Radiosurgery (SRS)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Device: 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.

Radiation: Fractionated Whole Brain Radiation Therapy (WBRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Device: 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.

Radiation: Fractionated Stereotactic Radiation Therapy (FSRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Device: Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.




Primary Outcome Measures :
  1. Change in Blood Brain Barrier (BBB)/Blood Tumor Barrier (BTB) permeability (per minute) in patients with brain metastases undergoing radiation therapy. [ Time Frame: Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment ]
    An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability, per minute, during and after fractionated (total dose spread out over time) Whole Brain Radiation Therapy (WBRT) or single fraction (single-dose) Stereotactic Radiosurgery (SRS).

  2. Change in magnitude and regional variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) permeability (per minute) in tumor, tumor margin, normal brain and brain metastases [ Time Frame: Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment ]
    An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute).


Secondary Outcome Measures :
  1. Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) [ Time Frame: Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment ]
  2. Investigate whether changes in Magnetic Resonance Imaging (MRI) parameters can be used as a marker for early prediction of treatment response in brain metastases. [ Time Frame: Data is expected to be evaluated beginning 6 months post radiation treatment of the last patient on study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031237


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Yue Cao, Ph.D. University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02031237     History of Changes
Other Study ID Numbers: UMCC 2005.003
HUM00043426 ( Other Identifier: University of Michigan )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases