Status:
WITHDRAWN
Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Brain Tumors
Eligibility:
All Genders
18-80 years
Brief Summary
Normal tissue response is critical for brain radiotherapy, especially for dose escalation which carries with it an increased incidence of radiation-induced brain injury. Although radiation toxicity an...
Detailed Description
Research Question: Our goal is to answer the following three research questions in this study: 1. What is the dose response curve (degree of radiation complications/radiological changes vs. radiatio...
Eligibility Criteria
Inclusion
- 1\. Histologically confirmed diagnosis of slow growing brain tumors that requires radiotherapy, e.g., meningioma, low grade glioma or anaplastic astrocytomas.
- 2\. A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration.
- 3\. Karnofsky performance status ≥60. 4. Ability to undergo MR imaging with the use of Gadolinium contrast. 5. Ability to undergo brain fMRI. 6. Patient must sign a study specific informed consent form. Patients who cannot provide consent due to cognitive impairment will not be enrolled in the study. The investigators will follow the recently published guidelines (Binder \& Guze, Am. J. Psy., 155, 1649-1650, 1998) to assess the subject's understanding of the procedure and his/her decision making capacity,.
Exclusion
- 1\. Any condition including allergy to Gadolinium contrast, metallic implants or cardiac pace makers that makes the candidate ineligible for MR imaging. These criteria will be determined by an MRI research screening form signed by the subject.
- 2\. Any condition including taking anti-anxiety medicines such as Benzodiazepines or requiring sedative to overcome claustrophobia that makes the candidate ineligible brain fMRI.
- 3\. Karnofsky performance status of ≤60 4. Prior history of radiation therapy to the brain 5. Pregnancy 6. Significant medical or neurological disorders that would affect the outcome of the evaluations and/or make a successful MRI/fMRI unduly difficult 7. Major psychiatric conditions, whether medicated or unmedicated, as such conditions can affect the validity of the evaluations
Key Trial Info
Start Date :
May 14 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01212237
Start Date
May 14 2012
End Date
April 13 2013
Last Update
July 29 2019
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065