MRI Staging in Colon Cancer
Primary Purpose
Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MRI 3 tesla
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer
Eligibility Criteria
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.
Sites / Locations
- Vejle Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI colon cancer
Arm Description
MRI scan of patients with colon cancer
Outcomes
Primary Outcome Measures
Is MRI usefull in colon cancer patients
Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04391933
Brief Title
MRI Staging in Colon Cancer
Official Title
MRI Staging in Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI colon cancer
Arm Type
Other
Arm Description
MRI scan of patients with colon cancer
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI 3 tesla
Intervention Description
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.
Primary Outcome Measure Information:
Title
Is MRI usefull in colon cancer patients
Description
Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren R Rafaelsen, MD, DMSc
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.sygehuslillebaelt.dk/wm223295
Description
hospital
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://komite.regionsyddanmark.dk/wm258128
Available IPD/Information Identifier
CPR
Learn more about this trial
MRI Staging in Colon Cancer
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