Peripheral Arterial DiseasePhase 4NCT00955617
DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
A Phase 4 study testing Contrast-enhanced MRA - Imaging examination in people with Peripheral Arterial Disease, run by Guerbet at 1 site in France.
Trial summary
This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Contrast-enhanced MRA - Imaging examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, aged ≥ 18 years
- Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
Who cannot join
- Patients with severely impaired renal function with an eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
- Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
- Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases
This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Contrast-enhanced MRA - Imaging examination
- Keywords
- Dotarem, Gadovist, Peripheral arterial disease, MRA
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced MRA - Imaging examinationOther
Also called Dotarem-enhanced MRA, Gadovist-enhanced MRA
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
| Study group | Role | What they receive |
|---|---|---|
| Dotarem / Gadovist | Experimental | Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2 Receives: Other: Contrast-enhanced MRA - Imaging examination |
| Gadovist / Dotarem | Experimental | Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2 Receives: Other: Contrast-enhanced MRA - Imaging examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Image Quality of MRA Images
Number of images quoted with excellent and more than adequate quality in each group.
Image quality will be assessed on a 5-point scale:
- Excellent
- More than adequate
- Adequate
- Less than adequate
- Non-diagnostic
Each image is analysed by 4 readers.
Measured: MRA examination
Secondary outcomes (2)
Diagnostic Confidence
Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.
Each image is analysed by 4 readers.
Measured: MRA examination
Signal Intensity
Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.
Measured: MRA examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guerbet, Study director, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955617
- Sponsor's protocol ID
- DGD-44-052
- Status last verified
- Oct 2012
- First submitted
- 6 Aug 2009
- Last updated
- 2 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases
- ClinicalTrials.gov ID
- NCT00955617
- Acronym / sponsor ID
- DGD-44-052
- Conditions
- Peripheral Arterial Disease
- Keywords
- Dotarem, Gadovist, Peripheral arterial disease, MRA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 2 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dotarem / Gadovist | Experimental | Other: Contrast-enhanced MRA - Imaging examinationContrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2 |
| Gadovist / Dotarem | Experimental | Other: Contrast-enhanced MRA - Imaging examinationContrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female or male, aged ≥ 18 years
- Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
Key exclusion criteria (3 listed)
- Patients with severely impaired renal function with an eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
- Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
- Patient who had a major cardiovascular event within 30 days prior to the inclusion.
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 |
|---|---|---|
| Contrast-enhanced MRA - Imaging examinationAlso: Dotarem-enhanced MRA, Gadovist-enhanced MRAAdministration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist) | Other | Dotarem / Gadovist, Gadovist / Dotarem |
Primary outcome
Overall Image Quality of MRA Images
Time frame: MRA examination
Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale: 1. Excellent 2. More than adequate 3. Adequate 4. Less than adequate 5. Non-diagnostic Each image is analysed by 4 readers.
2 secondary outcomes
Diagnostic Confidence
Time frame: MRA examination
Signal Intensity
Time frame: MRA examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guerbet study director
Guerbet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrast-enhanced MRA - Imaging examination in people with Peripheral Arterial Disease, run by Guerbet at 1 site in France.
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 2 inclusion and 3 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 2 Nov 2012. 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 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?
Yes. Results are posted in the registry (first posted 2 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Image Quality of MRA Images (time frame: MRA examination). 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 2 Nov 2012.