DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Michigan Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Neoplasms

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

Phase: N/A

Status: Recruiting

Sponsored by: University of Michigan Cancer Center

Official(s) and/or principal investigator(s):
Yue Cao, Ph.D., Principal Investigator, Affiliation: University of Michigan

Overall contact:
Yue Cao, Ph.D., Phone: 734-936-8695, Email: yuecao@umich.edu

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Yue Cao, Ph.D., Phone: 734-936-8695, Email: yuecao@umich.edu

University of Michigan Hosptial, Ann Arbor, Michigan 48109, United States; Recruiting
Yue Cao, Ph.D., Phone: 734-936-8695, Email: yuecao@umich.edu
Yue Cao, Ph.D., Principal Investigator
Additional Information

Starting date: July 2004
Last updated: May 18, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017