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

April 26, 2017 updated by: Dr.Dinesh Manoharan, All India Institute of Medical Sciences, New Delhi

Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Appropriateness of the treatment recieved
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

June 7, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (ESTIMATE)

June 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IESC/T-457/29.11.2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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