Clinical trial NCT05727007: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Keywords: colon
cancer
computed tomography
magnetic resonance
diffusion
preoperative
staging
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2023-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will employ a prospective design
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic accuracy in T stage
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Diagnostic accuracy in N stage
timeFrame: 1 month postoperatively
measure: Diagnostic accuracy in the retroperitoneal resection margin
timeFrame: 1 month postoperatively
measure: Diagnostic accuracy in peritoneal or nearby organ infiltration
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Department of Surgery, University Hospital of Larissa
Study officials:
affiliation: University Hospital of Larissa
name: George Tzovaras, Prof
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Effrosyni Bompou, MSc
role: PRINCIPAL_INVESTIGATOR
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