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

Sponsor

All India Institute of Medical Sciences, New Delhi (Other)

Overall Status

Completed

CT.gov ID

NCT02160600

Collaborator

(none)

124

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Appropriateness of the treatment recieved [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	All India Institute of Medical Sciences	New Delhi	Delhi	India	110029

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 10, 2014

Last Update Posted:

Apr 27, 2017

Last Verified:

Apr 1, 2017

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Study Results

No Results Posted as of Apr 27, 2017