Observational Study of Ultravist in Patients Requiring CECT (INDEX)

January 19, 2015 updated by: Bayer

The Image Quality and Radiation Dose of CECT With Ultravist® in Patients With Abdominal Pelvic Disease - INDEX

It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11660

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

  • China
      • Many locations, China

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen and pelvis, including relevant vessels

Description

Inclusion Criteria:

  • Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.

Exclusion Criteria:

  • There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Iopromide (Ultravist, BAY86-4877)
CT enhancement for abdominal or pelvic scan. Generally doses of up to 1.5 g iodine per kg body weight are well tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Image quality evaluated by calculated CNR (Contrast to Noise Ratio)
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Image quality evaluated by calculated SNR (Signal Noise Ratio)
Time Frame: 1 day
1 day
Descriptive analysis of contrast medial injection protocol
Time Frame: 1 day
1 day
Radiation dose (CTDIvol)
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Bayer

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

September 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (ESTIMATE)

August 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15515
  • UV1011CN (OTHER: Company Internal)

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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Clinical Trials on Iopromide (Ultravist, BAY86-4877)

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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