Computed Tomography Perfusion Colorectal Cancer With Tumor Grade

February 22, 2018 updated by: Peter Edward Megala, Assiut University

Computed Tomography Perfusion of Colorectal Cancer in Correlation With Tumor Grade

Colorectal cancer is the third most commonly diagnosed cancer in the world. The 5-years survival rate depends on the tumor stage and grade at patient presentation. Individual treatment strategy based on the tumor stage and grade should be applied to improve the prognosis, So the pre-operative diagnostic evaluation and grading of colorectal cancer are important.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diagnosis of cancer colon is usually based on colonoscopy which provides direct visualization of the lesions and allows for biopsies. However the pre-operative specimens from endoscopic biopsies sometimes fail to grade tumor because of the lack of sufficient tissue. Recent improvements in computed tomography have allowed for minimally invasive evaluation of cancer colon. Quantitative iodine density measurement can be used to differentiate low and high grade colorectal cancer. However, debate continues regarding the correlation between tumor grade and computed tomography perfusion parameters of colorectal cancer demonstrating the need for further investigation in this area of research.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of medicine

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal mass pathologically proved to be adenocarcinoma by colonoscpoic biopsy

Description

Inclusion Criteria:

  • Any patient with primary colorectal mass

Exclusion Criteria:

  • Colorectal mass pathologically proved to be benign Female patient at child bearing period with suspected pregnancy Raised renal chemistry Hypersensitivity to contrast.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with colorectal adenocarcinoma
The patients will undergo computed tomography perfusion
Radiation: Computed tomography perfusion
Pre-contrast images will be obtained to identify the colorectal tumor location. Then Fifty milliliters of iopromide (Ultravist ) will be injected intra-venously at rate of 5 milliliter per second via an automatic pump injector for computed tomography perfusion scans. Computed tomography perfusion scans will be performed at the mid-portion of the tumor for 60seconds beginning 5 seconds after contrast injection. Then arterial input will be defined by using the mouse to place a circular region of interest and the tumor region of interest will be placed on the most enhanced area of the tumor. Tumor blood flow, blood volume, mean transient time & permeability surface measurements will be obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow of tumor
Time Frame: One month
Accuracy of blood flow of the tumor in prediction of tumor grade in correlation with histopathological results
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood volume of the tumor
Time Frame: One month
Accuracy of blood volume of the tumor in prediction of tumor grade in correlation with histopathological results
One month
Mean transient time of the tumor
Time Frame: One month
transient time of the tumor in prediction of tumor grade in correlation with histopathological results
One month
Permeability surface of the tumor
Time Frame: One month
Accuracy of permeability surface of the tumor in prediction of tumor grade in correlation with histopathological results
One month

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Peter E Megala, MBBCh, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

March 10, 2018

Primary Completion (Anticipated)

March 10, 2019

Study Completion (Anticipated)

July 10, 2019

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTPCRCICWTG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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