MTX Neurotoxicity in Children with ALL

Study ID
STU 082010-197

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Rayna Ross
214-456-2826
rayna.ross@childrens.com

Principal Investigator
Nancy Rollins

Summary

Children who have aLL and who are being treated by the Hematology-oncology division at uTSWMC and Children's Medical Center of Dallas are eligible for possible participation in this study. The DTi is not considered part of routine care in children with aLL. Children who participate will be imaged once times during their treatment; at least two years from the diagnosis of aLL. Routine MR will be acquired, followed by the diffusion tensor study if permission is given by the parent or guardian, which will add 10-15 minutes to the overall MR imaging time. The images obtained from the diffusion tensor study will be sent to a dedicated workstation and certain measurements of the white matter, referred to as metrics will be taken by the pediatric neuroradiologists. These measurements will be added to a database which will include only the patients' ages and no other identifying information. no contrast materials will be administered for this study. The sponsor will pay the expenses for the entire MR images, and analysis and sedation. all patients will be given an opportunity to undergo MR imaging without sedation. Should sedation be needed, we will use Propofol only, which is a short-acting anesthesia medicine given through a small tube in the vein (iV) by the anesthesiologist. Propofol starts working very quickly, usually in less than a minute. it is also a very short-acting medicine, wearing off in 5 to 20 minutes. The child will be monitored the entire time he/she is asleep to make sure they are breathing adequately and blood pressure is stable. neuropsychological testing will be done at approximately the same time as the MRi with DTi, at least two years from diagnosis. The neuropsychological testing will require approximately 3[1/2]) hours. The results of these studies will be made available to the participants; there will be no charge for the testing. expenses related to standard medical care for neurologic toxicity are the responsibility of the patient (or the responsibility of the patient's insurance provider or government program).

Participant Eligibility

Children from 2-18 years of age who are referred to Children[Single Quote]s Medical Center Dallas for treatment of ALL.