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

December 7, 2012 updated by: Milena Cerny, University of Lausanne Hospitals

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- Vaud
  - Lausanne, Vaud, Switzerland, 1011
    - Recruiting
    - University of Lausanne Hospitals
    - Contact:
      
      Milena Cerny, Resident
      
      Phone Number: 0041795561102
      
      Email: milena.cerny@chuv.ch
    - Contact:
      
      Sabine Schmidt Kobbe, MER
      
      Phone Number: 0041213144444
      
      Email: sabine.schmidt@chuv.ch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with a rectal cancer

Description

Inclusion Criteria:

rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

renal failure
allergy to iodinated contrast medium
contraindication to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 1 week before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and six weeks after the end of the neoadjuvant treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

Principal Investigator: Milena Cerny, University of Lausanne Hospitals
Principal Investigator: Sabine Schmidt Kobbe, Dr., University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)