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

NCT01988675 | Completed DMC

• 2 other identifiers: UMCC 2003.083HUM00040138
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.

  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 Outcomes (1)

• Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.

  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)

Study Arms (2)

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).

Radiation: Partial Brain Irradiation; Behavioral: Neuropsychological Testing; Behavioral: Quality of Life Questionnaire; Device: Magnetic Resonance Imaging (MRI) Assessments

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).

Radiation: Whole Brain Irradiation; Behavioral: Neuropsychological Testing; Behavioral: Quality of Life Questionnaire; Device: Magnetic Resonance Imaging (MRI) Assessments

Interventions

Whole Brain Irradiation RADIATION

Whole Brain Irradiation

Partial Brain Irradiation RADIATION

Partial Brain Irradiation

Neuropsychological Testing BEHAVIORAL

Partial Brain Irradiation; Whole Brain Irradiation

Quality of Life Questionnaire BEHAVIORAL

Partial Brain Irradiation; Whole Brain Irradiation

Magnetic Resonance Imaging (MRI) Assessments DEVICE

MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).

Partial Brain Irradiation; Whole Brain Irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving partial or whole brain radiation therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Hosptial

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Neuropsychological Tests; Magnetic Resonance Imaging; Physical Examination

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yue Cao, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: August 26, 2004
• Primary Completion: June 3, 2014
• Study Completion: June 3, 2014
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

US (1)