NCT02160600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

June 7, 2014

Last Update Submit

April 26, 2017

Conditions

Renal Cell CarcinomaRenal CystsTransitional Cell CarcinomaAML

Outcome Measures

Primary Outcomes (1)

  • Appropriateness of the treatment recieved

    1 year

Study Arms (2)

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

Standard multiphase CTOTHER
Standard
split bolus Dual energy CTOTHER
split bolus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan
  • Patients who are referred for CT Urography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Carcinoma, Renal CellCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.

Study Record Dates

First Submitted

June 7, 2014

First Posted

June 10, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IN(1)