ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic MassesNCT06939075
Role of Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses
An observational study of ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses
- What is being tested?
- ROLE OF Cross sectional imaging modalities in the diagnosis and characterization of colonic masses
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Adults (>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available
Who may be able to join
- Adults (>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available.
Who cannot join
- • 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
About this study
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).
Read more
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.
- Conditions
- ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses
- Being tested
- ROLE OF Cross sectional imaging modalities in the diagnosis and characterization of colonic masses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROLE OF Cross sectional imaging modalities in the diagnosis and characterization of colonic massesDiagnostic test
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
- CT Scan: To evaluate mass morphology, size, and lymph node involvement.
- MRI: To assess tissue composition, characterization and diffusion restriction.
- Colonoscopy and Biopsy: Gold standard reference to assess the diagnostic accuracy for different
What is being measured
The primary outcome is the main question the study is designed to answer.
• Accuracy, sensitivity, and specificity of imaging modalities in detecting & diagnosis of colonic masses
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start24 Jul 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic MassesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Kamal Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939075
- Sponsor's protocol ID
- Diagnosis of colonic masses
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses
- ClinicalTrials.gov ID
- NCT06939075
- Acronym / sponsor ID
- Diagnosis of colonic masses
- Conditions
- ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Jul 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults (>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available
Key inclusion criteria (1 listed)
- Adults (>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available.
Key exclusion criteria (3 listed)
- • Patients with contraindications to contrast imaging as sensitivity to contrast media or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROLE OF Cross sectional imaging modalities in the diagnosis and characterization of colonic massesStudy tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): * CT Scan: To evaluate mass morphology, size, and lymph node involvement. * MRI: To assess tissue composition, characterization and diffusion restriction. * Colonoscopy and Biopsy: Gold standard reference to assess the diagnostic accuracy for different | Diagnostic test | – |
Primary outcome
• Accuracy, sensitivity, and specificity of imaging modalities in detecting & diagnosis of colonic masses
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ROLE OF Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Accuracy, sensitivity, and specificity of imaging modalities in detecting & diagnosis of colonic masses (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.