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Observational Study of Ultravist in Patients Requiring CECT (INDEX)

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ClinicalTrials.gov Identifier: NCT01415414
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diagnostic Imaging Drug: Iopromide (Ultravist, BAY86-4877)

Study Design

Study Type : Observational
Actual Enrollment : 11660 participants
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
Study Start Date : September 2011
Primary Completion Date : July 2012
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Iopromide
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Image quality evaluated by calculated CNR (Contrast to Noise Ratio) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Image quality evaluated by calculated SNR (Signal Noise Ratio) [ Time Frame: 1 day ]
  2. Descriptive analysis of contrast medial injection protocol [ Time Frame: 1 day ]
  3. Radiation dose (CTDIvol) [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415414


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01415414     History of Changes
Other Study ID Numbers: 15515
UV1011CN ( Other Identifier: Company Internal )
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Bayer:
Image quality
CNR
SNR
Abdominal
Pelvic