Observational Study of Ultravist in Patients Requiring CECT (INDEX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01415414
First received: August 10, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Diagnostic Imaging
Drug: Iopromide (Ultravist, BAY86-4877)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Image Quality and Radiation Dose of CECT With Ultravist® in Patients With Abdominal Pelvic Disease - INDEX

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Image quality evaluated by calculated CNR (Contrast to Noise Ratio) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Image quality evaluated by calculated SNR (Signal Noise Ratio) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Descriptive analysis of contrast medial injection protocol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Radiation dose (CTDIvol) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 12500
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415414

Locations
China
Many locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01415414     History of Changes
Other Study ID Numbers: 15515, UV1011CN
Study First Received: August 10, 2011
Last Updated: September 9, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Image quality
CNR
SNR
Abdominal
Pelvic

ClinicalTrials.gov processed this record on April 23, 2014