CT and MRI in Preoperative Colon Cancer Staging

NCT05727007 | Completed

• 1 other identifier: CTMR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms

Keywords

colon; cancer; computed tomography; magnetic resonance; diffusion; preoperative; staging

Outcome Measures

Primary Outcomes (1)

• 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)

  1 month postoperatively

Secondary Outcomes (3)

• Diagnostic accuracy in N stage

  1 month postoperatively

• Diagnostic accuracy in the retroperitoneal resection margin

  1 month postoperatively

• Diagnostic accuracy in peritoneal or nearby organ infiltration

  1 month postoperatively

Study Arms (1)

MRI in colon cancer

EXPERIMENTAL

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; Diagnostic Test: CT in colon cancer

Interventions

MRI in colon cancer DIAGNOSTIC_TEST

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

MRI in colon cancer

CT in colon cancer DIAGNOSTIC_TEST

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

MRI in colon cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Thessaly: collaborator

Study Sites (1)

Department of Surgery, University Hospital of Larissa

Larissa, 41110, Greece

Location

Related Publications (15)

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  PMID: 11309435 BACKGROUND

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  PMID: 26102418 BACKGROUND

• Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.

  PMID: 23017669 BACKGROUND

• Nerad E, Lambregts DM, Kersten EL, Maas M, Bakers FC, van den Bosch HC, Grabsch HI, Beets-Tan RG, Lahaye MJ. MRI for Local Staging of Colon Cancer: Can MRI Become the Optimal Staging Modality for Patients With Colon Cancer? Dis Colon Rectum. 2017 Apr;60(4):385-392. doi: 10.1097/DCR.0000000000000794.

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  PMID: 29627288 BACKGROUND

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MeSH Terms

Conditions

Colonic Neoplasms; Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• George Tzovaras, Prof

  University Hospital of Larissa

  STUDY CHAIR

• Effrosyni Bompou, MSc

  University Hospital of Larissa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effrosyni Bompou Principal Investigator

Model Details: The study will employ a prospective design

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 14, 2023
• Study Start: January 23, 2019
• Primary Completion: March 15, 2023
• Study Completion: May 15, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)