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CT and MRI in Preoperative Colon Cancer Staging

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05727007
Enrollment
120
Registered
2023-02-14
Start date
2019-01-23
Completion date
2023-05-15
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTMRI 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_TESTCT 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

Sponsors

University of Thessaly
CollaboratorOTHER
Larissa University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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

Intervention model description

The study will employ a prospective design

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy in T stage1 month postoperativelyEvaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)

Secondary

MeasureTime frameDescription
Diagnostic accuracy in N stage1 month postoperativelyEvaluation 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 margin1 month postoperativelyEvaluation 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 infiltration1 month postoperativelyEvaluation of diagnostic accuracy in the peritoneal or nearby organ infiltration. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026