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

This study is currently recruiting participants.
Verified December 2012 by University of Lausanne Hospitals
Sponsor:
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

December 2, 2012
December 7, 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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01745874 on ClinicalTrials.gov Archive Site
Tumoral regression after neoadjuvant treatment [ Time Frame: baseline and six weeks after the end of the neoadjuvant treatment ] [ Designated as safety issue: No ]
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
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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
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Non-Probability Sample

patients with a rectal cancer

Rectal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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
Both
18 Years to 95 Years
No
Not Provided
Switzerland
 
NCT01745874
247/12
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP