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Observational Study of Ultravist in Patients Requiring CECT (INDEX)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01415414
First received: August 10, 2011
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  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:

MedlinePlus related topics: Noise
Drug Information available for: Iopromide
U.S. FDA Resources

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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01415414     History of Changes
Other Study ID Numbers: 15515, UV1011CN
Study First Received: August 10, 2011
Last Updated: September 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Image quality
CNR
SNR
Abdominal
Pelvic

ClinicalTrials.gov processed this record on June 17, 2013