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

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988675
• Other study ID #: UMCC 2003.083
• Secondary ID: HUM00040138
• Status: Completed
• Start date: August 26, 2004
• Est. completion date: June 3, 2014

Study information

• Verified date: June 2018
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 3, 2014
• Est. primary completion date: June 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Radiation:
• Whole Brain Irradiation

• Partial Brain Irradiation

Behavioral:
• Neuropsychological Testing

• Quality of Life Questionnaire

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).

Locations

Country	Name	City	State
United States	University of Michigan Hosptial	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.	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)