Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-02 @ 4:54 PM
Study NCT ID:
NCT02160600
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2014-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2014-06-07', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appropriateness of the treatment recieved', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma', 'Renal Cysts', 'Transitional Cell Carcinoma', 'AML']}, 'descriptionModule': {'briefSummary': 'To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass evaluation in terms of appropriateness of treatment received after diagnosis. To determine SBDECT diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan\n* Patients who are referred for CT Urography\n\nExclusion Criteria:\n\n* Patients not willing to participate in the study\n* Age \\<18 yrs\n* Pregnant females\n* Patients with previous h/o serious allergic reactions or Contrast allergy\n* Impaired renal function (estimated GFR\\<45mL/min/mm2)\n* Sonographically proven benign renal mass needing no further evaluation'}, 'identificationModule': {'nctId': 'NCT02160600', 'briefTitle': 'Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.', 'orgStudyIdInfo': {'id': 'IESC/T-457/29.11.2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'split bolus', 'description': 'Patients will undergo diagnostic Split bolus DECT scan', 'interventionNames': ['Other: split bolus Dual energy CT']}, {'type': 'EXPERIMENTAL', 'label': 'Standard', 'description': 'Patients will undergo routine multiphase diagnostic CT', 'interventionNames': ['Other: Standard multiphase CT']}], 'interventions': [{'name': 'Standard multiphase CT', 'type': 'OTHER', 'armGroupLabels': ['Standard']}, {'name': 'split bolus Dual energy CT', 'type': 'OTHER', 'armGroupLabels': ['split bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110029', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.', 'investigatorFullName': 'Dr.Dinesh Manoharan', 'investigatorAffiliation': 'All India Institute of Medical Sciences'}}}}