CT and MRI in Preoperative Colon Cancer Staging

October 5, 2023 updated by: Effrosyni Bompou, Larissa University Hospital

Evaluation of Computed Tomography and Magnetic Diffusion Resonance Imaging in the Preoperative Staging of Colon Cancer

The objective of this study is the evaluation of different imaging methods for the optimal preoperative staging of colon cancer patients. Imaging findings will be compared with the histopathologic results of the specimen following surgical resection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over the last years a significant improvement in the treatment of patients with colon cancer has been reported. This has been attributed to the improvement of the staging techniques, as well as the optimization of the surgical management. However, the current five-year survival rates of colon cancer patients in European countries ranges from 32% to 64%. This variation could be due to treatment discrepancies and the lack of adherence to the international guidelines.

Surgical treatment of colon cancer includes the radical resection of the tumour (colectomy). Following resection, the specimen is histopathologically examined, the disease is staged and further treatment is determined. Neoadjuvant treatment (radiotherapy or/and chemotherapy) for colon cancer has not been yet approved, unlike rectal cancer, where neoadjuvant treatment is recommended for specific disease stages.

Preoperative staging of colon cancer aims to identify those patients with remote metastatic disease, who will, more likely, not benefit from upward surgery. Recent developments in colon cancer management, demanding more precise local disease staging, to identify those patients who will likely benefit from neoadjuvant chemotherapy, are still at a clinical trial stage.

Preoperative treatment depends on the disease stage, which is defined by the tumour's invasion in the colonic wall, the dissemination in nearby organs or lymph nodes, and the presence of distal metastases. The stage is first evaluated radiologically and then confirmed via histopathological examination of the specimen. Imaging is an already approved tool for the staging of colonic cancer, while in some studies the combination of different imaging methods has been reported to improve the initial evaluation.

Over the last years, evaluation of the circumferential resection margin (CRM) is also recommended in the preoperative staging of patients with colon cancer. This assessment is particularly important for tumours located at the cecum, right, or left colon, since these areas lack of mobile mesocolon and therefore it is possible to infiltrate the retroperitoneal resection margin.

Nevertheless, the retroperitoneal invasion of these tumours has not been evaluated adequately as a preoperative marker for both local recurrence and for the selection of patients who may benefit from neoadjuvant treatment. In various studies the percentage of retroperitoneal resection margin's infiltration was between 7-10% for cecum and right colon adenocarcinomas, while its presence was identified as a risk factor for local recurrence. The retroperitoneal surface infiltration was preoperatively evaluated with the combination of imaging methods and the findings were postoperatively compared with the histopathological features of the specimen.

A more precise, imaging based, preoperative staging, could lead to a more targeted neoadjuvant treatment for patients with advanced disease, with the introduction of chemo- and/or radiotherapy. This approach could result to the downstaging of the tumour, with better short and long term oncological results.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Larissa, Greece, 41110
        • Department of Surgery, University Hospital of Larissa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed colonic adenocarcinoma
  • Patient 18 to 90 years old
  • Abscence of comorbidities that may affect treatment
  • Signed informed consent of the patient

Exclusion Criteria:

  • Inability to receive or contraindication for intravenous contrast
  • Renal impairment
  • Previous allergies to intravenous contrasts
  • Incompatible implants with magnetic resonance imaging
  • Claustrophobia
  • Active sepsis or systemic infection
  • Untreated physical and mental disability
  • Lack of compliance with the protocol process
  • Non-granting of signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI in colon cancer
All prospectively included patients with colon cancer will be preoperatively submitted to MRI for staging. The evaluation of the diagnostic accuracy will be based on the cross-examination with the CT scan and the pathology results
Diagnostic test: MRI in colon cancer
The MRI protocol will include the following imaging series: T1 and T2 in axial and coronal plane before the administration of intravenous contrast, diffuse weight imaging in axial plane and T1 after the administration of intravenous contrast
Diagnostic test: CT in colon cancer
The CT scan protocol will include the following: per os and intravenous administration of contrast, axial slices of 0.3mm thickness and reconstruction per 1mm, multi-planar reformation and three-dimensional volume rendering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy in T stage
Time Frame: 1 month postoperatively
Evaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy in N stage
Time Frame: 1 month postoperatively
Evaluation of diagnostic accuracy in the presence of local or distant metastatic lymph nodes. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
1 month postoperatively
Diagnostic accuracy in the retroperitoneal resection margin
Time Frame: 1 month postoperatively
Evaluation of diagnostic accuracy in the retroperitoneal resection margin. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
1 month postoperatively
Diagnostic accuracy in peritoneal or nearby organ infiltration
Time Frame: 1 month postoperatively
Evaluation of diagnostic accuracy in the peritoneal or nearby organ infiltration. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Collaborators

University of Thessaly

Investigators

  • Study Chair: George Tzovaras, Prof, University Hospital of Larissa
  • Principal Investigator: Effrosyni Bompou, MSc, University Hospital of Larissa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2019

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual patient data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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