Diagnostic ImagingPhase 4NCT00382317
A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
A Phase 4 study testing Iobitridol in people with Diagnostic Imaging, run by Guerbet at 2 sites in 2 countries.
Trial summary
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- Iobitridol
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Feb 2008
- Phase
- Phase 4
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female having reached legal majority age and up to 85 years included.
- Scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pre-therapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material).
- Female of childbearing potential must have effective contraception (contraceptive pill or intra-uterine device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.
Who cannot join
- Patients with overt non-compensated heart failure.
- Patients with hemodynamic instability.
- Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP [systolic blood pressure) over or equal to 180 mm Hg or DBP [diastolic blood pressure] over or equal to 110 mm Hg)
- Patients with known severe renal failure (defined as creatinine clearance < 30 ml/min as calculated by the Cockroft and Gault formula).
- Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
- Patients with known thyreotoxicosis.
- Patients with history of immediate or delayed major hypersensitivity reaction to iodinated contrast media.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
- Conditions
- Diagnostic Imaging
- Being tested
- Iobitridol
- Keywords
- MSCT indications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IobitridolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Corinne Dubourdieu, PhD, Study chair, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382317
- Sponsor's protocol ID
- ISO-44-009
- Status last verified
- Nov 2008
- First submitted
- 28 Sep 2006
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications
- ClinicalTrials.gov ID
- NCT00382317
- Acronym / sponsor ID
- ISO-44-009
- Conditions
- Diagnostic Imaging
- Keywords
- MSCT indications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 29 Sep 2006 (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.
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female having reached legal majority age and up to 85 years included.
- Scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pre-therapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material).
- Female of childbearing potential must have effective contraception (contraceptive pill or intra-uterine device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.
Key exclusion criteria (7 listed)
- Patients with overt non-compensated heart failure.
- Patients with hemodynamic instability.
- Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP [systolic blood pressure) over or equal to 180 mm Hg or DBP [diastolic blood pressure] over or equal to 110 mm Hg)
- Patients with known severe renal failure (defined as creatinine clearance < 30 ml/min as calculated by the Cockroft and Gault formula).
- Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
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 |
|---|---|---|
| Iobitridol | Drug | – |
Primary outcome
Not reported in the source record.
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 26 Nov 2008.
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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.
Corinne Dubourdieu, PhD study chair
Guerbet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iobitridol in people with Diagnostic Imaging, run by Guerbet at 2 sites in 2 countries.
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 7 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 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 26 Nov 2008.