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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745874
• Other study ID #: 247/12
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2012
• Last updated: December 7, 2012
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2012
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

• renal failure

• allergy to iodinated contrast medium

• contraindication to MRI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment	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.	baseline and 1 week before surgery	No
Secondary	Tumoral regression after 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.	baseline and six weeks after the end of the neoadjuvant treatment	No