Back to resultsDual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial
Primary Purpose
Renal Cell Carcinoma, Renal Cysts, Transitional Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Standard multiphase CT
split bolus Dual energy CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan
- Patients who are referred for CT Urography
Exclusion Criteria:
- Patients not willing to participate in the study
- Age <18 yrs
- Pregnant females
- Patients with previous h/o serious allergic reactions or Contrast allergy
- Impaired renal function (estimated GFR<45mL/min/mm2)
- Sonographically proven benign renal mass needing no further evaluation
Sites / Locations
- All India Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
split bolus
Standard
Arm Description
Patients will undergo diagnostic Split bolus DECT scan
Patients will undergo routine multiphase diagnostic CT
Outcomes
Primary Outcome Measures
Appropriateness of the treatment recieved
Secondary Outcome Measures
Full Information
NCT ID
NCT02160600
First Posted
June 7, 2014
Last Updated
April 26, 2017
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT02160600
Brief Title
Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial
Official Title
Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Renal Cysts, Transitional Cell Carcinoma, AML
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
split bolus
Arm Type
Experimental
Arm Description
Patients will undergo diagnostic Split bolus DECT scan
Arm Title
Standard
Arm Type
Experimental
Arm Description
Patients will undergo routine multiphase diagnostic CT
Intervention Type
Other
Intervention Name(s)
Standard multiphase CT
Intervention Type
Other
Intervention Name(s)
split bolus Dual energy CT
Primary Outcome Measure Information:
Title
Appropriateness of the treatment recieved
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan
Patients who are referred for CT Urography
Exclusion Criteria:
Patients not willing to participate in the study
Age <18 yrs
Pregnant females
Patients with previous h/o serious allergic reactions or Contrast allergy
Impaired renal function (estimated GFR<45mL/min/mm2)
Sonographically proven benign renal mass needing no further evaluation
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
12. IPD Sharing Statement
Learn more about this trial
Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial
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