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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Milena Cerny, University of Lausanne Hospitals

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.

Condition or disease
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 : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
Study Start Date : October 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with a rectal cancer

Inclusion Criteria:

  • rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

  • renal failure
  • allergy to iodinated contrast medium
  • contraindication to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745874

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University of Lausanne Hospitals Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Milena Cerny, Resident    0041795561102   
Contact: Sabine Schmidt Kobbe, MER    0041213144444   
Sponsors and Collaborators
University of Lausanne Hospitals
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Principal Investigator: Milena Cerny University of Lausanne Hospitals
Principal Investigator: Sabine Schmidt Kobbe, Dr. University of Lausanne Hospitals
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Responsible Party: Milena Cerny, Dr. Milena Cerny, University of Lausanne Hospitals Identifier: NCT01745874    
Other Study ID Numbers: 247/12
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012
Keywords provided by Milena Cerny, University of Lausanne Hospitals:
Rectal cancer
Whole-body MRI
preoperative staging
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases