check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

15515

ClinicalTrials.gov Identifier:

NCT01415414

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.