Diagnostic ImagingINDEXNCT01415414
Observational Study of Ultravist in Patients Requiring CECT
An observational study of Diagnostic Imaging, run by Bayer at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- Iopromide (Ultravist, BAY86-4877)
- How many people
- 11,660 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen and pelvis, including relevant vessels
Who may be able to join
- Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.
Who cannot join
- There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Image Quality and Radiation Dose of CECT With Ultravist® in Patients With Abdominal Pelvic Disease - INDEX
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.
- Conditions
- Diagnostic Imaging
- Being tested
- Iopromide (Ultravist, BAY86-4877)
- Keywords
- Image quality, CNR, SNR, Abdominal, Pelvic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Iopromide (Ultravist, BAY86-4877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality evaluated by calculated CNR (Contrast to Noise Ratio)
Measured: 1 day
Secondary outcomes (3)
Image quality evaluated by calculated SNR (Signal Noise Ratio)
Measured: 1 day
Descriptive analysis of contrast medial injection protocol
Measured: 1 day
Radiation dose (CTDIvol)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415414
- Sponsor's protocol ID
- 15515
- Other IDs
- UV1011CN
- Acronym
- INDEX
- Status last verified
- Jan 2015
- First submitted
- 10 Aug 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Image Quality and Radiation Dose of CECT With Ultravist® in Patients With Abdominal Pelvic Disease - INDEX
- ClinicalTrials.gov ID
- NCT01415414
- Acronym / sponsor ID
- INDEX / 15515
- Conditions
- Diagnostic Imaging
- Keywords
- Image quality, CNR, SNR, Abdominal, Pelvic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,660 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Iopromide (Ultravist, BAY86-4877) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen and pelvis, including relevant vessels
Key inclusion criteria (1 listed)
- Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.
Key exclusion criteria (1 listed)
- There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Group 1 |
Primary outcome
Image quality evaluated by calculated CNR (Contrast to Noise Ratio)
Time frame: 1 day
3 secondary outcomes
Image quality evaluated by calculated SNR (Signal Noise Ratio)
Time frame: 1 day
Descriptive analysis of contrast medial injection protocol
Time frame: 1 day
Radiation dose (CTDIvol)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Imaging, run by Bayer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality evaluated by calculated CNR (Contrast to Noise Ratio) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.