Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT03448302
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computed Tomography Perfusion Colorectal Cancer With Tumor Grade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003570', 'term': 'Cytidine Triphosphate'}], 'ancestors': [{'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood flow of tumor', 'timeFrame': 'One month', 'description': 'Accuracy of blood flow of the tumor in prediction of tumor grade in correlation with histopathological results'}], 'secondaryOutcomes': [{'measure': 'Blood volume of the tumor', 'timeFrame': 'One month', 'description': 'Accuracy of blood volume of the tumor in prediction of tumor grade in correlation with histopathological results'}, {'measure': 'Mean transient time of the tumor', 'timeFrame': 'One month', 'description': 'transient time of the tumor in prediction of tumor grade in correlation with histopathological results'}, {'measure': 'Permeability surface of the tumor', 'timeFrame': 'One month', 'description': 'Accuracy of permeability surface of the tumor in prediction of tumor grade in correlation with histopathological results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colo-rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '24809317', 'type': 'BACKGROUND', '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.'}, {'pmid': '22563293', 'type': 'BACKGROUND', '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(Suppl 1):S89-97. doi: 10.3348/kjr.2012.13.S1.S89. Epub 2012 Apr 23.'}, {'pmid': '24434157', 'type': 'BACKGROUND', '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.'}, {'pmid': '22514101', 'type': 'BACKGROUND', 'citation': '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': '27766137', 'type': 'BACKGROUND', 'citation': 'Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with colorectal mass pathologically proved to be adenocarcinoma by colonoscpoic biopsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with primary colorectal mass\n\nExclusion Criteria:\n\n* Colorectal mass pathologically proved to be benign Female patient at child bearing period with suspected pregnancy Raised renal chemistry Hypersensitivity to contrast.'}, 'identificationModule': {'nctId': 'NCT03448302', 'briefTitle': 'Computed Tomography Perfusion Colorectal Cancer With Tumor Grade', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Computed Tomography Perfusion of Colorectal Cancer in Correlation With Tumor Grade', 'orgStudyIdInfo': {'id': 'CTPCRCICWTG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with colorectal adenocarcinoma', 'description': 'The patients will undergo computed tomography perfusion', 'interventionNames': ['Radiation: Computed tomography perfusion']}], 'interventions': [{'name': 'Computed tomography perfusion', 'type': 'RADIATION', 'description': '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.', 'armGroupLabels': ['Patients with colorectal adenocarcinoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Afaf A Hassan, MD', 'role': 'CONTACT', 'email': 'Drafaf.kader@yahoo.com', 'phone': '01095229303'}, {'name': 'Mostafa A ElSharkawy, MD', 'role': 'CONTACT', 'email': 'drmostafamri@yahoo.com', 'phone': '01223971443'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Afaf A Hassan, MD', 'role': 'CONTACT', 'email': 'Drafaf.kader@yahoo.com', 'phone': '01095229303'}, {'name': 'Mostafa A El-Sharkawy, MD', 'role': 'CONTACT', 'email': 'drmostafamri@yahoo.com', 'phone': '01223971443'}], 'overallOfficials': [{'name': 'Peter E Megala, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Peter Edward Megala', 'investigatorAffiliation': 'Assiut University'}}}}