Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors
| Tracking Information | |||||
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| First Received Date ICMJE | July 26, 2007 | ||||
| Last Updated Date | September 5, 2012 | ||||
| Start Date ICMJE | March 2005 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparison of CT and MRI scans of patients with renal cell carcinoma in evaluating each of nine imaging variables. [ Time Frame: 4 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00507884 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 | Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors | ||||
| Official Title ICMJE | Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors | ||||
| Brief Summary | The goal of this clinical research study is to find out if "3 Tesla" MRI is as good as CT scan in the evaluation of kidney tumor(s). Objectives: To provide preliminary data to enable subsequent development of an MRI protocol at 3 Tesla for evaluation of renal tumors and their vascular supply, which can be adopted in patients who are unable to undergo CT evaluation. |
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| Detailed Description | "3 Tesla" MRI is a new MRI scanner that in theory, can produce better images than currently available MRI scanners. Currently, CT scanning is the main way of evaluating tumors in the kidneys. However, there are some patients who cannot have CT scans (usually, because of allergy to CT contrast medium or kidney damage/failure). It is with these patients that researchers are hoping to use a technique (using MRI) that is as good as CT scanning. As part of your standard of care, your doctor is requesting a CT scan of your kidneys and abdomen. If you take part in this study, you will have a "3 Tesla" MRI scan of your kidneys and abdomen as well, within 15 days following your routine CT. For the "3 Tesla" MRI scan, you will be lying flat on the MRI scanner, and as with a regular scan, you will have a small needle placed in a vein in your arm to inject the contrast dye. A diuretic, Lasix, will be given to help distend the internal tubes in the kidney to help view your kidney better. The MRI scan will take between 1-2 hours to perform. As with regular scans, you may be asked to hold your breath on occasions. If there is a concern about your kidney function, blood (about 1 teaspoon) will be drawn to test your kidney function before you have the MRI. Your participation in the study will be complete at the end of the MRI scan. The routine CT scan will be the main decision making examination. However, if the MRI shows something different and potentially relevant to your care, your referring physician will be informed. This is an investigational study. A total of 45 patients will take part in this study. All will be enrolled at MD Anderson. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Study participants with renal tumors scheduled to have a CT scan of the kidneys and abdomen. |
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| Condition ICMJE | Kidney Neoplasms | ||||
| Intervention ICMJE | Procedure: 3 Tesla MRI Scan
MRI of the kidneys and abdomen to be done within 15 days following the routine CT and lasting 1 - 2 hours. |
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| Study Group/Cohort (s) | 3 Tesla MRI
Patients with renal tumors scheduled to have a CT scan of the kidneys and abdomen.
Intervention: Procedure: 3 Tesla MRI Scan |
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00507884 | ||||
| Other Study ID Numbers ICMJE | 2004-0875 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| 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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