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Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial

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ClinicalTrials.gov Identifier: NCT02160600
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Dinesh Manoharan, All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Renal Cysts Transitional Cell Carcinoma AML Other: Standard multiphase CT Other: split bolus Dual energy CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.
Study Start Date : April 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: split bolus
Patients will undergo diagnostic Split bolus DECT scan
Other: split bolus Dual energy CT
Experimental: Standard
Patients will undergo routine multiphase diagnostic CT
Other: Standard multiphase CT



Primary Outcome Measures :
  1. Appropriateness of the treatment recieved [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160600


Locations
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India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
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Responsible Party: Dr.Dinesh Manoharan, Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract., All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02160600    
Other Study ID Numbers: IESC/T-457/29.11.2013
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases