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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
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:
The main purpose of this 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 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Diagnostic Test: MRI 3 tesla Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Malene R Pedersen, PhD +45 79405300 malene.roland.vils.pedersen@rsyd.dk
Contact: Søren R Rafaelsen, MD, DMSc, +4579405336 soeren.rafael.rafaelsen@rsyd.dk

Locations
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Denmark
Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Malene R Pedersen, PhD    +45 79405300    malene.roland.vils.pedersen@rsyd.dk   
Contact: Soeren R Rafaelsen, MD, DMSc    +45 79405336    soeren.rafael.rafaelsen@rsyd.dk   
Sponsors and Collaborators
Vejle Hospital
Investigators
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Study Chair: Søren R Rafaelsen, MD, DMSc Vejle Hospital

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: CPR

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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT04391933    
Other Study ID Numbers: MR Colon
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases