check_circleStudy Completed

Diagnostic Imaging

Observational study of Ultravist in patients requiring CECT

Trial 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.

Key Participants Requirements

Sex

Both

Age

0 - N/A
  • - Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.

  • - There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics

Trial summary

Enrollment Goal
11660
Trial Dates
September 2011 - November 2013
Phase
N/A
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, China

Primary Outcome

  • Image quality evaluated by calculated CNR (Contrast to Noise Ratio)
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Image quality evaluated by calculated SNR (Signal Noise Ratio)
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    No
  • Descriptive analysis of contrast medial injection protocol
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    No
  • Radiation dose (CTDIvol)
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    No

Trial design

The Image quality and Radiation Dose of CECT with Ultravist® in Patients with Abdominal Pelvic Disease - INDEX
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A