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NCT04391933 Clinical Trial

MRI Staging in Colon Cancer

Colon Cancer Clinical Trial

Official title:
MRI Staging in Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04391933
Other study ID # MR Colon
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2020

Study information
Verified date May 2020
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to investigate whether magnetic ressonance imaging (MRI) can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study will investigate whether MRI is useful and better than CT scanning in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.

Description:

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 restriction during 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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with colon cancer - 18 years old or older - Written and verbally informed consent Exclusion Criteria: - Pacemakers, implanted medical pumps, and nerve stimulators - Cochlea implants and cerebral aneurism clips will in some cases be absolute contraindications to MRI examinations. - Previous treatment with radiation and or chemotherapy - Serious disease that contraindicates surgical treatment, including severe heart disease - Any type of cancer other than of the colon (excluding skin cancer, cancer in situ, endometrial cancer, malignant melanoma) - Any other condition or disease that from the investigator's point of view makes it inappropriate for the patient to participate.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Vejle Hospital Vejle

Sponsors (1)
Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Is MRI usefull in colon cancer patients Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition. 2 years
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