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Clinical Trials/NCT01745874
NCT01745874
Unknown
Not Applicable

Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment

University of Lausanne Hospitals1 site in 1 country20 target enrollmentOctober 2012
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
University of Lausanne Hospitals
Enrollment
20
Locations
1
Primary Endpoint
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment
Last Updated
13 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Milena Cerny

Dr. Milena Cerny

University of Lausanne Hospitals

Eligibility Criteria

Inclusion Criteria

  • rectal cancer T3 N+ or T3 or T4

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Tumoral regression after neoadjuvant treatment(baseline and six weeks after the end of the neoadjuvant treatment)

Study Sites (1)

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