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

• Conditions: Rectal Cancer

• Registration Number: NCT01745874
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-10
• Status Verified: 2012-12
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-07
• Last Update Submitted: 2012-12-07
• Study First Posted: 2012-12-10
• Last Update Posted: 2012-12-10
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• rectal cancer T3 N+ or T3 or T4

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment	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

Name	Time	Method
Tumoral regression after neoadjuvant treatment	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.

Trial Locations

Locations (1)

University of Lausanne Hospitals; 🇨🇭 Lausanne, Vaud, Switzerland