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Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Milena Cerny, University of Lausanne Hospitals.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Milena Cerny, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01745874
First received: December 2, 2012
Last updated: December 7, 2012
Last verified: December 2012
| Tracking Information | |||||||
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| First Received Date ICMJE | December 2, 2012 | ||||||
| Last Updated Date | December 7, 2012 | ||||||
| Start Date ICMJE | October 2012 | ||||||
| Estimated Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment [ Time Frame: baseline and 1 week before surgery ] We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
Tumoral regression after neoadjuvant treatment [ Time Frame: baseline and six weeks after the end of the neoadjuvant treatment ] Evaluate the tumoral regression after neoadjuvant treatment on the MRI by the measurement of the ADC (attenuation diffusion coefficient) increase and compare the results to the measure of the SUV (standard uptake value) decrease on the FDG-PET-CT. |
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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 | Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging | ||||||
| Official Title ICMJE | Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment | ||||||
| Brief Summary | The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer. | ||||||
| Detailed Description | Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery). Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another. WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation . |
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| Study Type ICMJE | Observational | ||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | patients with a rectal cancer | ||||||
| Condition ICMJE | Rectal Cancer | ||||||
| Intervention ICMJE | Not Provided | ||||||
| Study Groups/Cohorts | 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 | Unknown status | ||||||
| Estimated Enrollment ICMJE | 20 | ||||||
| Estimated Completion Date | October 2013 | ||||||
| Estimated Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 95 Years (Adult, Senior) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Switzerland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01745874 | ||||||
| Other Study ID Numbers ICMJE | 247/12 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Milena Cerny, University of Lausanne Hospitals | ||||||
| Study Sponsor ICMJE | University of Lausanne Hospitals | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | University of Lausanne Hospitals | ||||||
| Verification Date | December 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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