Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01212237
First received: June 22, 2010
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Brain Tumors
Procedure: fMRI Evaluation
Phase 0

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 25
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)
Groups/Cohorts Assigned Interventions
fMRI Evaluation

All patients will undergo the following standard imaging and radiotherapy procedures will be performed for each patient:

  1. Standard MRI for radiotherapy treatment planning which takes about 60 minutes.
  2. Radiotherapy treatment simulation with CT.
  3. Radiotherapy treatment planning
  4. Radiotherapy treatment
  5. Routine follow-up every 3 months after the radiotherapy.

Special Procedures.

The following special imaging and radiotherapy procedures will be performed for each patient:

  1. fMRI (30 minutes)
  2. The 3MS examination, administered every 3 months during routine follow-up for one year after the completion of the radiotherapy.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with brain tumors (astrocytoma, meningioma, low grad glioma)

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212237

Contacts
Contact: Jenghwa Chang, Ph.D. 212-746-6305 jec2046@med.cornell.edu
Contact: Mei-Ki Chan, M.A. 212-746-9297 mbc2004@med.cornell.edu

Locations
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    mbc2004@med.cornell.edu   
Contact: Jenghwa Chang, Ph.D.    212-746-6305    jec2046@med.cornell.edu   
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.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jenghwa Chang, Ph.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01212237     History of Changes
Other Study ID Numbers: 1003010928
Study First Received: June 22, 2010
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
glioma
meningioma
anaplastic astrocytoma

ClinicalTrials.gov processed this record on September 18, 2014