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NCT01445288 · ClinicalTrials.gov registry record
Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 76
- Enrollment target
NCT01445288: Completed study, sponsored by National Cancer Institute (NCI).
NCT01445288 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445288 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 76 participants
- Enrollment target
Study Summary
This study will analyze the effects of radiation given to children who have tumors of the central nervous system (CNS). Researchers want to learn more about changes in the quality of life that patients may experience as a result of radiation. Patients ages 21 and younger who have a primary CNS tumor and who have not received radiation previously may be eligible for this study. They will have a medical history and physical examination. Collection of blood (about 2-1/2 tablespoons) and urine will be done, as well as a pregnancy test. Patients will complete neuropsychological tests, which provide information about their changes in functioning over time. An expert in psychology will give a number of tests, and the patient's parents or guardian will be asked to complete a questionnaire about the patient's behavior. Also, patients will be given a quality of life questionnaire to complete and vision and hearing tests. The radiation itself is prescribed by patients' doctors and is not part of this study. Magnetic resonance imaging (MRI) will give researchers information about the tumor and brain, through several scanning sequences . MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. Patients will lie on a table that slides into the enclosed tunnel of the scanner. They will need to lie still, and medication may be given to help them to do that. They may be in the scanner for up to 2 hours. As the scanner takes pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. A contrast agent will be administered, to allow images be seen more clearly. Blood and urine tests will be conducted after the first dose of radiation. MRI scans will be done 2 weeks after patients finish radiation therapy and again at 6 to 8 weeks, 6 months, 12 months, and yearly. Also at those follow-up periods, patients will undergo similar procedures as previously, including blood and urine tests and neuropsychologic
Primary Outcome
Measurement of VEGF, bFGF, thrombospondin, TNF-a, IL-12, IL-8, and MMP in blood and urine specimens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2006-12-05 |
What the finished NCT01445288 record still lists
NCT01445288 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01445288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01445288 about?
NCT01445288 is a clinical study titled "Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors". This study will analyze the effects of radiation given to children who have tumors of the central nervous system (CNS). Researchers want to learn more about changes in the quality of life that patients may experience as a result of radiation. Patients ages 21 and younger who have a primary CNS tumo...
What is the current status of trial NCT01445288?
This trial is currently completed. The enrollment target is 76 participants. The study started on 2006-12-05.
Who is sponsoring clinical trial NCT01445288?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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