NCT03448302

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 22, 2018

Last Update Submit

February 22, 2018

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Blood flow of tumor

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

    One month

Secondary Outcomes (3)

  • Blood volume of the tumor

    One month

  • Mean transient time of the tumor

    One month

  • Permeability surface of the tumor

    One month

Study Arms (1)

Patients with colorectal adenocarcinoma

The patients will undergo computed tomography perfusion

Radiation: Computed tomography perfusion

Interventions

Computed tomography perfusionRADIATION

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.

Patients with colorectal adenocarcinoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Any patient with primary colorectal mass

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 24809317BACKGROUND

  • 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.

    PMID: 22563293BACKGROUND

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

    PMID: 24434157BACKGROUND

  • 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.

    PMID: 22514101BACKGROUND

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

    PMID: 27766137BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Peter E Megala, MBBCh

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Afaf A Hassan, MD

CONTACT

01095229303Drafaf.kader@yahoo.com

Mostafa A El-Sharkawy, MD

CONTACT

01223971443drmostafamri@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

March 10, 2018

Primary Completion

March 10, 2019

Study Completion

July 10, 2019

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)