Dual Energy CT vs Standard Triple Phase CT-A Randomised C... | NCT02160600

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

NCT02160600

Sponsor

All India Institute of Medical Sciences

Status

Completed

Last Update Posted

Apr 27, 2017Actual

Enrollment

124Actual

Phase

Not Applicable

Conditions

Renal Cell Carcinoma
Renal Cysts
Transitional Cell Carcinoma
AML

Interventions

Standard multiphase CT
split bolus Dual energy CT

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jun 7, 2014

First Submission Date that Met QC Criteria

Jun 9, 2014

First Posted Date

Jun 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2017

Last Update Posted Date

Apr 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 SciencesPrincipal Investigator

Lead Sponsor

All India Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
split bolus	Experimental	Patients will undergo diagnostic Split bolus DECT scan	Other: split bolus Dual energy CT
Standard	Experimental	Patients will undergo routine multiphase diagnostic CT	Other: Standard multiphase CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard multiphase CT	Other		Standard
split bolus Dual energy CT

Measure	Description	Time Frame
Appropriateness of the treatment recieved		1 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
All India Institute of Medical Sciences		New Delhi	National Capital Territory of Delhi	110029	India

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell
D002295	Carcinoma, Transitional Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided