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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01745874

Enrollment

Registered

2012-12-10

Start date

2012-10-31

Completion date

2013-10-31

Last updated

2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal cancer, Whole-body MRI, FDG-PET-CT, preoperative staging

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

* rectal cancer T3 N+ or T3 or T4

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment	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.

Secondary

Measure	Time frame	Description
Tumoral regression after neoadjuvant treatment	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.

Countries

Switzerland

Outcome results