Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy
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 and limiting dose for anatomically critical structures of the brain have been well studied and documented, little is known for functionally critical brain regions and treatment of cognitive sequelae of cranial radiotherapy is limited. The objective of this clinical protocol is to accumulate preliminary data for future studies aiming to quantify dose response for functionally critical brain regions for brain radiotherapy. We plan to achieve this objective by correlating the radiation-induced complications and radiological changes with the radiation dose to the selected functionally critical brain regions for 25 patients. Each participating patient will receive brain fMRI to identify brain regions for processing visual, working memory and language functions. The image co-registration algorithm developed previously by our group will be used to co-register these regions on the CT scans for radiotherapy treatment planning for radiation dose calculation. Radiation-induced changes in cognitive functions will be evaluated using the modified mini mental status exam (3MS) and fMRI during the routine follow-up. The knowledge derived from this study might significantly improve the quality of life and allow safer dose escalation for patients receiving brain radiotherapy.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Phase I Study of Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy|
- fMRI to Measure Functional Changes of Criticial Brain Regions Over Time [ Time Frame: pre-radiation therapy and 6 months post radiation therapy ] [ Designated as safety issue: No ]fMRI screening at baseline and 6 months after the completion of radiation therapy to observe the original functionality of the brain (pre-radiation therapy) and the functionality of the brain after radiation therapy. If the radiation has damaged any functional areas, the difference in performance will be evident in the 6 month fMRI.
- MMSE - expanded (Mini-Mental Status Examination)- to Document Changes in Functionality of Critical Brain Regions [ Time Frame: pre-radiation therapy, 3, 6, 9, 12 months post-radiation therapy ] [ Designated as safety issue: No ]The expanded MMSE (mini-mental status exam) routinely used to screen the overall cognitive functions of patients following brain radiotherapy. The MMSE will help to track brain function at a great interval than the fMRI. It will show changes in the brain over time.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
All patients will undergo the following standard imaging and radiotherapy procedures will be performed for each patient:
The following special imaging and radiotherapy procedures will be performed for each patient:
Procedure: fMRI Evaluation
Functional magnetic resonance imaging (fMRI) uses MR imaging to measure the tiny metabolic changes that take place in an active part of the brain. fMRIs are used for many reasons, for example, to determine precisely which part of the brain is handling critical functions such as thought, speech, movement and sensation, to help assess the effects of stroke, trauma or degenerative disease (such as Alzheimer's) on brain function, and to guide the planning of surgery and radiation therapy.
Other Name: fMRI
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01212237
|Contact: Jenghwa Chang, Ph.D.||email@example.com|
|Contact: Mei-Ki Chan, M.A.||firstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mei-Ki Chan, M.A. 212-746-9297 email@example.com|
|Contact: Jenghwa Chang, Ph.D. 212-746-6305 firstname.lastname@example.org|
|Principal Investigator: Jenghwa Chang, Ph.D.|
|Sub-Investigator: Susan Pannullo, M.D.|
|Sub-Investigator: Henning Voss, M.D.|
|Sub-Investigator: Denise Correa, Ph.D.|
|Sub-Investigator: Linda Heier, M.D.|
|Sub-Investigator: Ilhami Kovanlikaya, M.D.|
|Sub-Investigator: James Root, Ph.D.|
|Principal Investigator:||Jenghwa Chang, Ph.D.||Weill Medical College of Cornell University|