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CT and MRI in Preoperative Colon Cancer Staging

Primary Purpose

Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
MRI in colon cancer
CT in colon cancer
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring colon, cancer, computed tomography, magnetic resonance, diffusion, preoperative, staging

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, University Hospital of Larissa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI in colon cancer

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnostic accuracy in T stage
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
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
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
Evaluation of diagnostic accuracy in the peritoneal or nearby organ infiltration. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)

Full Information

First Posted
January 25, 2023
Last Updated
October 5, 2023
Sponsor
Larissa University Hospital
Collaborators
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT05727007
Brief Title
CT and MRI in Preoperative Colon Cancer Staging
Official Title
Evaluation of Computed Tomography and Magnetic Diffusion Resonance Imaging in the Preoperative Staging of Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital
Collaborators
University of Thessaly

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
colon, cancer, computed tomography, magnetic resonance, diffusion, preoperative, staging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The 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
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI in colon cancer
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI in colon cancer
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
CT in colon cancer
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic accuracy in T stage
Description
Evaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Time Frame
1 month postoperatively
Secondary Outcome Measure Information:
Title
Diagnostic accuracy in N stage
Description
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)
Time Frame
1 month postoperatively
Title
Diagnostic accuracy in the retroperitoneal resection margin
Description
Evaluation of diagnostic accuracy in the retroperitoneal resection margin. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Time Frame
1 month postoperatively
Title
Diagnostic accuracy in peritoneal or nearby organ infiltration
Description
Evaluation of diagnostic accuracy in the peritoneal or nearby organ infiltration. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Time Frame
1 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Tzovaras, Prof
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Effrosyni Bompou, MSc
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual patient data
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CT and MRI in Preoperative Colon Cancer Staging

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