Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy

NCT01212237 | Withdrawn

• 1 other identifier: 1003010928
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Tumors

Keywords

glioma; meningioma; anaplastic astrocytoma

Outcome Measures

Primary Outcomes (1)

• fMRI to Measure Functional Changes of Criticial Brain Regions Over Time

  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.

  pre-radiation therapy and 6 months post radiation therapy

Secondary Outcomes (1)

• MMSE - expanded (Mini-Mental Status Examination)- to Document Changes in Functionality of Critical Brain Regions

  pre-radiation therapy, 3, 6, 9, 12 months post-radiation therapy

Study Arms (1)

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

Interventions

fMRI Evaluation PROCEDURE

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.

Also known as: fMRI

fMRI Evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. Histologically confirmed diagnosis of slow growing brain tumors that requires radiotherapy, e.g., meningioma, low grade glioma or anaplastic astrocytomas.
• \. A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration.
• \. 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,.

You may not qualify if:

• \. 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.
• \. Any condition including taking anti-anxiety medicines such as Benzodiazepines or requiring sedative to overcome claustrophobia that makes the candidate ineligible brain fMRI.
• \. 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Meningioma; Astrocytoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Study Officials

• Jenghwa Chang, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: September 30, 2010
• Study Start: May 14, 2012
• Primary Completion: April 13, 2013
• Study Completion: April 13, 2013
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

US (1)