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NCT01415414 Clinical Trial

Observational Study of Ultravist in Patients Requiring CECT

Diagnostic Imaging Clinical Trial

— INDEX  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01415414
Other study ID # 15515
Secondary ID UV1011CN
Status Completed
Phase N/A
First received August 10, 2011
Last updated January 19, 2015
Start date September 2011
Est. completion date November 2013

Study information
Verified date January 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 11660
Est. completion date November 2013
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Image quality evaluated by calculated CNR (Contrast to Noise Ratio) 1 day No
Secondary Image quality evaluated by calculated SNR (Signal Noise Ratio) 1 day No
Secondary Descriptive analysis of contrast medial injection protocol 1 day No
Secondary Radiation dose (CTDIvol) 1 day No
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