CClinicalTrials.gg
Status unknownNCT03448302Updated Feb 28, 2018

Computed Tomography Perfusion Colorectal Cancer With Tumor Grade

An observational study in Colo-rectal Cancer, sponsored by Assiut University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colo-rectal Cancer
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Any patient with primary colorectal mass

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with colorectal adenocarcinoma

    The patients will undergo computed tomography perfusion

    Radiation: Computed tomography perfusion

Interventions

  • RadiationComputed 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.

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What researchers measure

Primary outcomes

  1. Blood flow of tumor

    Accuracy of blood flow of the tumor in prediction of tumor grade in correlation with histopathological results

    Time frame: One month

Secondary outcomes

  1. Blood volume of the tumor

    Accuracy of blood volume of the tumor in prediction of tumor grade in correlation with histopathological results

    Time frame: One month

  2. Mean transient time of the tumor

    transient time of the tumor in prediction of tumor grade in correlation with histopathological results

    Time frame: One month

  3. Permeability surface of the tumor

    Accuracy of permeability surface of the tumor in prediction of tumor grade in correlation with histopathological results

    Time frame: One month

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 24809317 ↗
  • 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(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. PubMed 22563293 ↗
  • Goh V, Glynne-Jones R. Perfusion CT imaging of colorectal cancer. Br J Radiol. 2014 Feb;87(1034):20130811. doi: 10.1259/bjr.20130811. PubMed 24434157 ↗
  • 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. PubMed 22514101 ↗
  • Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016. PubMed 27766137 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03448302
Lead sponsor
Assiut University
Responsible party
Peter Edward Megala (Principal investigator, Assiut University) — Principal investigator
First posted
Feb 28, 2018
Start date
Mar 10, 2018 (estimated)
Primary completion
Mar 10, 2019 (estimated)
Completion
Jul 10, 2019 (estimated)
Last update
Feb 28, 2018

Study contacts

Afaf A Hassan, MD
Contact
Drafaf.kader@yahoo.com
01095229303
Mostafa A El-Sharkawy, MD
Contact
drmostafamri@yahoo.com
01223971443
Peter E Megala, MBBCh
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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