CT and MRI in Preoperative Colon Cancer Staging

Sponsor

Larissa University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05727007

Collaborator

University of Thessaly (Other)

120

Enrollment

Location

Arm

49.7

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Diagnostic Test: MRI in colon cancer Diagnostic Test: CT in colon cancer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study will employ a prospective designThe study will employ a prospective design

Masking:

None (Open Label)

Masking Description:

There will be no blindness at the level of the patient, the treating physicians (surgeon, oncologist, radiologist) and the researcher who will record the data

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 23, 2019

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy in T stage [1 month postoperatively]
Evaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)

Secondary Outcome Measures

Diagnostic accuracy in N stage [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)
Diagnostic accuracy in the retroperitoneal resection margin [1 month postoperatively]
Evaluation of diagnostic accuracy in the retroperitoneal resection margin. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Diagnostic accuracy in peritoneal or nearby organ infiltration [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)