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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03448302
Other study ID # CTPCRCICWTG
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 22, 2018
Last updated February 22, 2018
Start date March 10, 2018
Est. completion date July 10, 2019

Study information

Verified date February 2018
Source Assiut University
Contact Afaf A Hassan, MD
Phone 01095229303
Email Drafaf.kader@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date July 10, 2019
Est. primary completion date March 10, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Dighe S, Castellano E, Blake H, Jeyadevan N, Koh MU, Orten M, Swift I, Brown G. Perfusion CT to assess angiogenesis in colon cancer: technical limitations and practical challenges. Br J Radiol. 2012 Oct;85(1018):e814-25. doi: 10.1259/bjr/19855447. Epub 2012 Apr 18. — View Citation

Goh V, Glynne-Jones R. Perfusion CT imaging of colorectal cancer. Br J Radiol. 2014 Feb;87(1034):20130811. doi: 10.1259/bjr.20130811. Review. — View Citation

Kim JW, Jeong YY, Chang NK, Heo SH, Shin SS, Lee JH, Hur YH, Kang HK. Perfusion CT in colorectal cancer: comparison of perfusion parameters with tumor grade and microvessel density. Korean J Radiol. 2012 Jan-Feb;13 Suppl 1:S89-97. doi: 10.3348/kjr.2012.13.S1.S89. Epub 2012 Apr 23. Erratum in: Korean J Radiol. 2012 Jul-Aug;13(4):522. — View Citation

Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016. Review. — View Citation

Sun H, Xu Y, Yang Q, Wang W. Assessment of tumor grade and angiogenesis in colorectal cancer: whole-volume perfusion CT. Acad Radiol. 2014 Jun;21(6):750-7. doi: 10.1016/j.acra.2014.02.011. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood flow of tumor Accuracy of blood flow of the tumor in prediction of tumor grade in correlation with histopathological results One month
Secondary Blood volume of the tumor Accuracy of blood volume of the tumor in prediction of tumor grade in correlation with histopathological results One month
Secondary Mean transient time of the tumor transient time of the tumor in prediction of tumor grade in correlation with histopathological results One month
Secondary Permeability surface of the tumor Accuracy of permeability surface of the tumor in prediction of tumor grade in correlation with histopathological results One month
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