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 30, 2014
Last verified: September 2014
  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: 11660
Study Start Date: September 2011
Study Completion Date: November 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 30, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Image quality
CNR
SNR
Abdominal
Pelvic

Additional relevant MeSH terms:
Iopromide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014