MRI Staging in Colon Cancer

NCT04391933 | Completed

• 1 other identifier: MR Colon
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Is MRI usefull in colon cancer patients

  Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition.

  2 years

Study Arms (1)

MRI colon cancer

OTHER

MRI scan of patients with colon cancer

Diagnostic Test: MRI 3 tesla

Interventions

MRI 3 tesla DIAGNOSTIC_TEST

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.

MRI colon cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with colon cancer
• years old or older
• Written and verbally informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Links

• hospital

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Søren R Rafaelsen, MD, DMSc

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)