Trial Condition(s):
Diagnostic Imaging
Observational study of Ultravist in patients requiring CECT (INDEX)
Bayer Identifier:
15515
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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
Trial Summary
Enrollment Goal
11660
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Image quality evaluated by calculated CNR (Contrast to Noise Ratio)Timeframe: 1 day
Secondary Outcome
- Image quality evaluated by calculated SNR (Signal Noise Ratio)Timeframe: 1 day
- Descriptive analysis of contrast medial injection protocolTimeframe: 1 day
- Radiation dose (CTDIvol)Timeframe: 1 day
Additional Information
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