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

• ClinicalTrials.gov Identifier: NCT01745874
• Recruitment Status: Unknown
• First Posted: December 10, 2012
• Last Update Posted: December 10, 2012
• Sponsor: University of Lausanne Hospitals
• Information provided by (Responsible Party): Milena Cerny, University of Lausanne Hospitals

Tracking Information

• First Submitted Date: December 2, 2012
• First Posted Date: December 10, 2012
• Last Update Posted Date: December 10, 2012
• Study Start Date: October 2012
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2012)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 7, 2012)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging
• Official Title: Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients with a rectal cancer
• Condition: Rectal Cancer
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 7, 2012): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2013
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 95 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01745874
• Other Study ID Numbers: 247/12
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Milena Cerny, University of Lausanne Hospitals
• Study Sponsor: University of Lausanne Hospitals
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Lausanne Hospitals
• Verification Date: December 2012