Study of Brain Tumors (Tectal Tumors) Using Magnetic Resonance Imaging
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 20, 2012 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00229814 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Brain Tumors (Tectal Tumors) Using Magnetic Resonance Imaging | ||||
| Official Title ICMJE | Magnetic Resonance Spectroscopic Analysis of Pediatric Tectal Tumors: Insight Into Pathology and Behavior | ||||
| Brief Summary | Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and spectroscopic features. There is debate whether they truly represent brainstem tumors or whether they are a site of benign cellular overgrowth. The majority of these tumors are pathologically benign and show no or minimal growth. Not all tectal plate tumors, however, have this typically benign course. Some can manifest a more aggressive behavior. There have been reports in the past attempting to analyze the histology and behavior of these tumors. None of the prior series looking at these tumors have included Magnetic Resonance Spectroscopy (MRS) analysis. It is interesting that according to where tumors occur in the brainstem usually indicates what their histology and behavior is. Although not absolute, we know that tumors can have a very poor prognosis versus an extremely good prognosis depending on their location in the brainstem. Yet there are always the cases that do not act in the typical fashion and this is where MRS can prove helpful. This study is being done to look at a region of the brain, called the tectal plate, in children. This part of the brain can be involved by tumors. Because of the location of the tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can look at the chemical make up of the brain. MRS may allow us to better understand the nature and behavior of these tumors. However, in order to understand disease in this area, we need to look at the normal chemical make up of the brain in children without tectal plate tumors. Healthy patients are being asked to participate as a normal volunteer. We anticipate having a total of 10 to 12 normal volunteers in the MRS study. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy volunteer children. |
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| Condition ICMJE | Tectal Plate Glioma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00229814 | ||||
| Other Study ID Numbers ICMJE | Tectal Tumors MRS | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Children's Healthcare of Atlanta | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Healthcare of Atlanta | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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