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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

Tracking Information
First Submitted Date December 2, 2012
First Posted Date December 10, 2012
Last Update Posted Date December 10, 2012
Study Start Date October 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2012)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 7, 2012)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging
Official Title 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 .

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with a rectal cancer
Condition Rectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 7, 2012)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

  • renal failure
  • allergy to iodinated contrast medium
  • contraindication to MRI
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01745874
Other Study ID Numbers 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 University of Lausanne Hospitals
Collaborators Not Provided
Investigators
Principal Investigator: Milena Cerny University of Lausanne Hospitals
Principal Investigator: Sabine Schmidt Kobbe, Dr. University of Lausanne Hospitals
PRS Account University of Lausanne Hospitals
Verification Date December 2012