MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier

June 5, 2018 updated by: University of Michigan Rogel Cancer Center
This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving partial or whole brain radiation therapy

Description

Inclusion Criteria:

  • Patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases.
  • Patients must be 18 years of age or older
  • Patients must sign a study specific consent form approved by the Institutional Review Board (IRB) of the University of Michigan prior to study entry.
  • Patients must have a neurological function class 1 or 2 with a Karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to 70.
  • Patients must have an expected life expectancy of greater than 6 months.

Exclusion Criteria:

  • Patients with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol.
  • Patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field.
  • Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan.
  • Prisoners are excluded.
  • Pregnant women are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Partial Brain Irradiation
Patients will receive partial brain irradiation for malignant or benign brain tumors as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).
Behavioral: Quality of Life Questionnaire
Radiation: Partial Brain Irradiation
Behavioral: Neuropsychological Testing
Device: Magnetic Resonance Imaging (MRI) Assessments
MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
Whole Brain Irradiation
Patients will receive whole brain irradiation for brain metastases as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).
Behavioral: Quality of Life Questionnaire
Behavioral: Neuropsychological Testing
Device: Magnetic Resonance Imaging (MRI) Assessments
MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
Radiation: Whole Brain Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
Time Frame: Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose.
Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.
Time Frame: Baseline, 6 weeks post radiation therapy (RT), 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
Changes in Magnetic Resonance Imagining (MRI) assessments will be compared graphically to changes in neurocognitive function and clinical symptoms. Parallel analysis will be conducted on each of the neurocognitive tests to determine if MRI assessments can identify patients at increased risk for later neurocognitive dysfunction.
Baseline, 6 weeks post radiation therapy (RT), 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Yue Cao, Ph.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2004

Primary Completion (Actual)

June 3, 2014

Study Completion (Actual)

June 3, 2014

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2003.083
  • HUM00040138 (Other Identifier: University of Michigan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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