MRI Staging in Colon Cancer
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|ClinicalTrials.gov Identifier: NCT04391933|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Diagnostic Test: MRI 3 tesla||Not Applicable|
Colon cancer is a frequent disease in Denmark with over 3200 new cases and about 1350 deaths per year.
CT scanning is currently the national standard method for determining the stage of disease planning for treatment. CT scan can sufficiently distinct between minor and advanced colon tumors. Prevalence of advanced tumors was well over 40% in the CT study from Vejle Hospital in 2013. Sensitivity and specificity of detection of advanced colon tumors in the CT study was approx. 70% and 80%, respectively. A small MRI pilot study showed higher sensitivity and specificity of 89% and 96%, respectively.
MRI scan is currently performed in most patients with rectal cancer, which has resulted in better treatment planning and increased survival. MRI scan of the rectum is documented with higher accuracy than CT scan. There has been reluctance to introduce MRI scan in patients with colon cancer, as the colon has more peristalsis than the rectum, and movement of the bowel can result in image quality reduction in MRI. However, in recent years MRI has become faster and thereby less sensitive to movements.
MRI scanning may in the future help to select the patients who will benefit from neoadjuvant treatment. In addition, with MRI it is possible to perform MRI diffusion measurements of the tumor, which gives an estimate of the tumor's cell density. It will also be possible to investigate whether this changes the MRI diffusion distriction with the neoadjuvant treatment.
This study is prospective and uses state of the art equipment with a 3 tesla MRI unit.
The main purpose of the study is to investigate whether MRI can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study investigates whether MRI is useful and better than CT in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI.|
|Masking:||None (Open Label)|
|Official Title:||MRI Staging in Colon Cancer|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
MRI colon cancer
MRI scan of patients with colon cancer
Diagnostic Test: MRI 3 tesla
MRI of colon cancer. Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI.
- Is MRI usefull in colon cancer patients [ Time Frame: 2 years ]Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391933
|Contact: Malene R Pedersen, PhD||+45 email@example.com|
|Contact: Søren R Rafaelsen, MD, DMSc,||+firstname.lastname@example.org|
|Study Chair:||Søren R Rafaelsen, MD, DMSc||Vejle Hospital|