Colo-rectal CancerNCT03448302
Computed Tomography Perfusion Colorectal Cancer With Tumor Grade
An observational study of Colo-rectal Cancer, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Computed tomography perfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2018to 10 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with colorectal mass pathologically proved to be adenocarcinoma by colonoscpoic biopsy
Who may be able to join
- Any patient with primary colorectal mass
Who cannot join
- Colorectal mass pathologically proved to be benign Female patient at child bearing period with suspected pregnancy Raised renal chemistry Hypersensitivity to contrast.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine
Asyut
Afaf A Hassan, MD, 01095229303, Drafaf.kader@yahoo.com
Mostafa A ElSharkawy, MD, 01223971443, drmostafamri@yahoo.com
About this study
Official title: 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.
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.
- Conditions
- Colo-rectal Cancer
- Being tested
- Computed tomography perfusion
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal adenocarcinoma | The patients will undergo computed tomography perfusion Receives: Radiation: Computed tomography perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow of tumor
Accuracy of blood flow of the tumor in prediction of tumor grade in correlation with histopathological results
Measured: One month
Secondary outcomes (3)
Blood volume of the tumor
Accuracy of blood volume of the tumor in prediction of tumor grade in correlation with histopathological results
Measured: One month
Mean transient time of the tumor
transient time of the tumor in prediction of tumor grade in correlation with histopathological results
Measured: One month
Permeability surface of the tumor
Accuracy of permeability surface of the tumor in prediction of tumor grade in correlation with histopathological results
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start10 Mar 2018 (estimated)
- Primary completion10 Mar 2019 (estimated)
- Study completion10 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Edward Megala, Assiut University
- Investigators
- Peter E Megala, MBBCh, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448302
- Sponsor's protocol ID
- CTPCRCICWTG
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24809317Kim 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.
PubMed 22563293Goh V, Glynne-Jones R. Perfusion CT imaging of colorectal cancer. Br J Radiol. 2014 Feb;87(1034):20130811. doi: 10.1259/bjr.20130811.
PubMed 24434157Dighe 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 22514101Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.
PubMed 27766137
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Perfusion of Colorectal Cancer in Correlation With Tumor Grade
- ClinicalTrials.gov ID
- NCT03448302
- Acronym / sponsor ID
- CTPCRCICWTG
- Conditions
- Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (estimated)
- Primary completion
- 10 Mar 2019 (estimated)
- Study completion
- 10 Jul 2019 (estimated)
- First posted
- 28 Feb 2018 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal adenocarcinoma | – | Radiation: Computed tomography perfusionThe patients will undergo computed tomography perfusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with colorectal mass pathologically proved to be adenocarcinoma by colonoscpoic biopsy
Key inclusion criteria (1 listed)
- Any patient with primary colorectal mass
Key exclusion criteria (1 listed)
- Colorectal mass pathologically proved to be benign Female patient at child bearing period with suspected pregnancy Raised renal chemistry Hypersensitivity to contrast.
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 |
|---|---|---|
| Computed tomography perfusionPre-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. | Radiation | Patients with colorectal adenocarcinoma |
Primary outcome
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
3 secondary outcomes
Blood volume of the tumor
Time frame: One month
Mean transient time of the tumor
Time frame: One month
Permeability surface of the tumor
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 24809317Sun 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.
- Background: PubMed 22563293Kim 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.
- Background: PubMed 24434157Goh V, Glynne-Jones R. Perfusion CT imaging of colorectal cancer. Br J Radiol. 2014 Feb;87(1034):20130811. doi: 10.1259/bjr.20130811.
- Background: PubMed 22514101Dighe 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.
- Background: PubMed 27766137Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Peter E Megala, MBBCh principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afaf A Hassan, MD (01095229303, Drafaf.kader@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow of tumor (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448302, which also lists 5 linked publications.
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 28 Feb 2018.