Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MRS Tumor)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01138813
First received: June 4, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | June 4, 2010 | ||||
| Last Updated Date | June 4, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism | ||||
| Official Title ICMJE | Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism | ||||
| Brief Summary | This study will evaluate the test-retest repeatability of lactate and other metabolites measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients radiographically diagnosed with glioma. These measurements will test whether the concentration of lactate in tumor will be higher than the concentration of lactate in normal tissue of the same patient. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Tissue |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher |
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| Condition ICMJE | Glioma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher |
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| 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 | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | February 2010 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01138813 | ||||
| Other Study ID Numbers ICMJE | 2010_027, 145 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | June 2010 | ||||
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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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