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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Milena Cerny, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01745874
First received: December 2, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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
Rectal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Tumoral regression after neoadjuvant treatment [ Time Frame: baseline and six weeks after the end of the neoadjuvant treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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 .

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with a rectal cancer

Criteria

Inclusion Criteria:

  • rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

  • renal failure
  • allergy to iodinated contrast medium
  • contraindication to MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745874

Locations
Switzerland
University of Lausanne Hospitals Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Milena Cerny, Resident    0041795561102    milena.cerny@chuv.ch   
Contact: Sabine Schmidt Kobbe, MER    0041213144444    sabine.schmidt@chuv.ch   
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Milena Cerny University of Lausanne Hospitals
Principal Investigator: Sabine Schmidt Kobbe, Dr. University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Milena Cerny, Dr. Milena Cerny, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01745874     History of Changes
Other Study ID Numbers: 247/12
Study First Received: December 2, 2012
Last Updated: December 7, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Rectal cancer
Whole-body MRI
FDG-PET-CT
preoperative staging

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 30, 2014