Role of Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses

July 5, 2025 updated by: Maram Kamal Ahmed, Assiut University

Colonic masses are frequently encountered in clinical practice and can be benign or malignant. Accurate characterization is crucial for optimal management. Traditional imaging techniques such as colonoscopy remain the gold standard; however, multi-modality imaging-including computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET)-has gained importance.

Colorectal cancer (CRC) is one of the most commonly diagnosed malignancies worldwide, ranking as the third most common cancer and the second leading cause of cancer-related mortality. According to the Global Cancer Observatory (GLOBOCAN), in 2020, there were approximately 1.9 million new cases of CRC and over 930,000 deaths. The incidence varies geographically, with higher rates in developed countries due to lifestyle factors, dietary habits, and genetic predispositions. Early detection through screening and imaging plays a pivotal role in reducing morbidity and mortality. (Sung et al., 2021).

Recent studies have demonstrated that multi-modality imaging improves diagnostic confidence in colonic lesions. CT colonography has been shown to have a sensitivity of approximately 96% for detecting polyps ≥10mm (Pickhardt et al., 2019). MRI provides superior soft tissue contrast, aiding in local tumor staging (Beets-Tan et al., 2020). These advancements underline the importance of integrating multiple imaging techniques for comprehensive colonic mass evaluation.

Staging of colorectal cancer is crucial for treatment planning and prognosis assessment. The TNM (Tumor, Node, Metastasis) staging system is widely used:

  • T (Tumor size and invasion): Ranges from T1 (tumor confined to the mucosa) to T4 (tumor invading adjacent structures).
  • N (Lymph node involvement): N0 (no nodal involvement) to N2 (extensive nodal spread).
  • M (Distant metastases): M0 (no metastases) to M1 (presence of metastases). Imaging plays a fundamental role in staging. CT is the primary modality for detecting lymph node involvement and distant metastases (Liu et al., 2020). MRI, particularly with diffusion-weighted imaging, provides superior soft-tissue contrast for local staging, especially in rectal cancer (Maas et al., 2019).

Colonoscopy with histopathological biopsy remains the gold standard for diagnosing colonic masses. It allows direct visualization, biopsy sampling, and polyp removal if necessary.

This study aims to evaluate the diagnostic accuracy and clinical utility of these imaging modalities in detecting and differentiating colonic masses.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Adults (>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available

Description

Inclusion Criteria:

  • Adults (>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available.

Exclusion Criteria:

  • • Patients with contraindications to contrast imaging as sensitivity to contrast media or renal impairment

    • Patient with contraindication for MRI e.g patients having a devices with Para magnetic effect e.g pacemakers and claustrophobia
    • Patients with prior colorectal cancer diagnosis or surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Accuracy, sensitivity, and specificity of imaging modalities in detecting & diagnosis of colonic masses
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 24, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 5, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diagnosis of colonic masses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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