Abdominal CTNCT01654354
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT
An observational study of Abdominal CT, run by Seoul National University Hospital.
Trial summary
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Abdominal CT
- What is being tested?
- NEOVIST 370 INJ.(Iopromide 768.86mg) and Ultravist 370 INJ.(Iopromide 768.86mg)
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2013
- How long will I take part?
- 8 Days
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject who performed scheduled CT scan, mostly postoperative state of stomach cancer
Who may be able to join
- Aged 20 to 75 years old.
- Subjects who need CT scan
- Subjects who are willing to participate in the study and to write the informed consent form.
Who cannot join
- Subjects with severe hepatopathy whose AST or ALT ≥ 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT ≥ UNL(upper normal limit) X 3
- Severe disorder of thyroid gland
- homocystinuria
- pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods
- Participation in another clinical trial within 30days of enrollment into this study.
About this study
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT
- Conditions
- Abdominal CT
- Being tested
- NEOVIST 370 INJ.(Iopromide 768.86mg), Ultravist 370 INJ.(Iopromide 768.86mg)
- Keywords
- Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEOVIST 370 INJ.(Iopromide 768.86mg)Drug
Ultravist 370 INJ.(Iopromide 768.86mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
imaging quality
Two readers evaluate image quality of the abdomen CT by four-points scale
Measured: end of study enrollment
Adverse reaction
Measured: immediate after CT scan
Secondary outcomes (1)
SNR (signal to noise ratio) / CNR (contrast to noise ratio)
ROI measurement at abdominal aorta and liver
Measured: at the end or enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CTStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Eun Cheon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654354
- Sponsor's protocol ID
- Neovist IIT
- Status last verified
- Jan 2014
- First submitted
- 20 Jul 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT
- ClinicalTrials.gov ID
- NCT01654354
- Acronym / sponsor ID
- Neovist IIT
- Conditions
- Abdominal CT
- Keywords
- Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jul 2012 (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.
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Days
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject who performed scheduled CT scan, mostly postoperative state of stomach cancer
Key inclusion criteria (3 listed)
- Aged 20 to 75 years old.
- Subjects who need CT scan
- Subjects who are willing to participate in the study and to write the informed consent form.
Key exclusion criteria (5 listed)
- Subjects with severe hepatopathy whose AST or ALT ≥ 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT ≥ UNL(upper normal limit) X 3
- Severe disorder of thyroid gland
- homocystinuria
- pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods
- Participation in another clinical trial within 30days of enrollment into this study.
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 |
|---|---|---|
| NEOVIST 370 INJ.(Iopromide 768.86mg) | Drug | – |
| Ultravist 370 INJ.(Iopromide 768.86mg) | Drug | – |
Primary outcome
imaging quality
Time frame: end of study enrollment
Two readers evaluate image quality of the abdomen CT by four-points scale
Adverse reaction
Time frame: immediate after CT scan
1 secondary outcome
SNR (signal to noise ratio) / CNR (contrast to noise ratio)
Time frame: at the end or enrollment
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 14 Jan 2014.
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Volunteer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal CT, run by Seoul National University Hospital.
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 3 inclusion and 5 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
imaging quality (time frame: end of study enrollment). The study lists 2 primary outcomes in all. 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 14 Jan 2014.