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Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging

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ClinicalTrials.gov Identifier: NCT01745874
Recruitment Status : Unknown
Verified December 2012 by Milena Cerny, University of Lausanne Hospitals.
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Milena Cerny, University of Lausanne Hospitals

December 2, 2012
December 10, 2012
December 10, 2012
October 2012
October 2013   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging
Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
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.

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 .

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patients with a rectal cancer
Rectal Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
Same as current
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

  • renal failure
  • allergy to iodinated contrast medium
  • contraindication to MRI
Sexes Eligible for Study: All
18 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01745874
247/12
No
Not Provided
Not Provided
Milena Cerny, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Principal Investigator: Milena Cerny University of Lausanne Hospitals
Principal Investigator: Sabine Schmidt Kobbe, Dr. University of Lausanne Hospitals
University of Lausanne Hospitals
December 2012