- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745874
Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging
Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Vaud
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Lausanne, Vaud, Switzerland, 1011
- Recruiting
- University of Lausanne Hospitals
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Contact:
- Milena Cerny, Resident
- Phone Number: 0041795561102
- Email: milena.cerny@chuv.ch
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Contact:
- Sabine Schmidt Kobbe, MER
- Phone Number: 0041213144444
- Email: sabine.schmidt@chuv.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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.
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baseline and 1 week before surgery
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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
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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.
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baseline and six weeks after the end of the neoadjuvant treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milena Cerny, University of Lausanne Hospitals
- Principal Investigator: Sabine Schmidt Kobbe, Dr., University of Lausanne Hospitals
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 247/12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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