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OpenTrials
Completed

NCT Number: NCT01415414

Observational Study of Ultravist in Patients Requiring CECT

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.

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Key information

Conditions

Diagnostic Imaging

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iopromide (Ultravist, BAY86-4877)

Drug

CT enhancement for abdominal or pelvic scan. Generally doses of up to 1.5 g iodine per kg body weight are well tolerated

Primary outcomes

  1. Image quality evaluated by calculated CNR (Contrast to Noise Ratio)

    Time frame: 1 day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: INDEX

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 12, 2011
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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