Cerebral Arterial DiseasesPhase 3NCT01010932

Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

A Phase 3 study testing Dotarem and TOF MRA in people with Cerebral Arterial Diseases, run by Guerbet at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cerebral Arterial Diseases
What is being tested?: Dotarem and TOF MRA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Dec 2010
Phase: Phase 3
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

Male or female, aged more than 18 years
Strongly suspected of having carotid or vertebral arterial disease
Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Who cannot join

Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
Contraindication to MRI
Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Trial locations and contacts

1 site in 1 country.

United States1 site

Guerbet LLC
Bloomington, Indiana, 47403

Other trials in United States

About this study

Official title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Read the detailed description

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Conditions: Cerebral Arterial Diseases
Being tested: Dotarem, TOF MRA
Keywords: carotid or vertebral artery disease, Contrast agent, MRA
Medical subject headings: Cerebral Arterial Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DotaremDrug
Also called Gadoterate meglumine
Each subject will receive one injection of Dotarem 0.2ml/kg
TOF MRAOther
Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)

Study groups in NCT01010932
Study group	Role	What they receive
Dotarem and TOF MRA	Experimental	Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. Receives: Drug: Dotarem; Other: TOF MRA

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical Failure Rate
Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).
Measured: 2 - 28 days
Sensitivity
Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).
Measured: 2-42 days
Specificity
Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).
Measured: 2 - 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Dec 2010

First posted10 Nov 2009 (estimated)
Study startOct 2009
Primary completionDec 2010
Study completionDec 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 Cerebral Arterial DiseasesStudies 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 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01010932
Sponsor's protocol ID: DGD-44-048
Status last verified: May 2016
First submitted: 9 Nov 2009
Last updated: 16 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Arterial Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease
ClinicalTrials.gov ID: NCT01010932
Acronym / sponsor ID: DGD-44-048
Conditions: Cerebral Arterial Diseases
Keywords: carotid or vertebral artery disease, Contrast agent, MRA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 10 Nov 2009 (estimated)
Results: Posted 25 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed description

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dotarem and TOF MRA	Experimental	Drug: Dotarem, Other: TOF MRAEach subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female, aged more than 18 years
Strongly suspected of having carotid or vertebral arterial disease
Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Key exclusion criteria (3 listed)

Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
Contraindication to MRI
Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

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
DotaremAlso: Gadoterate meglumineEach subject will receive one injection of Dotarem 0.2ml/kg	Drug	Dotarem and TOF MRA
TOF MRAEach subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)	Other	Dotarem and TOF MRA

Primary outcome

Technical Failure Rate
Time frame: 2 - 28 days
Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).
Sensitivity
Time frame: 2-42 days
Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).
Specificity
Time frame: 2 - 42 days
Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).

Results and safety

Results posted to the registry on 25 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TOF MRA Followed by Dotarem-enhanced MRA	222	200

Primary outcome: Technical Failure Rate

Time frame: 2 - 28 days. Number (95% Confidence Interval). Unit: percentage of arterial segments

Measure	Dotarem-enhanced MRA n = 198	TOF MRA n = 198
Reader 1	4.65 (3.87 to 5.44)	29.44 (27.74 to 31.13)
Reader 2	1.77 (1.28 to 2.26)	16.70 (15.31 to 18.09)
Reader 3	2.20 (1.65 to 2.75)	18.54 (17.10 to 19.99)

Population analysed: For 2 patients, MRA images were not analyzed because images were incomplete.

Primary outcome: Sensitivity

Time frame: 2-42 days. Number (95% Confidence Interval). Unit: percentage of stenotic segments

Measure	Dotarem-enhanced MRA n = 197	TOF MRA n = 197
Reader 1	58.46 (46.48 to 70.44)	53.85 (41.73 to 65.97)
Reader 2	63.08 (51.34 to 74.81)	63.08 (51.34 to 74.81)
Reader 3	53.85 (41.73 to 65.97)	49.23 (37.08 to 61.38)

Population analysed: For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.

Primary outcome: Specificity

Time frame: 2 - 42 days. Number (95% Confidence Interval). Unit: percentage of non-stenotic segments

Measure	Dotarem-enhanced MRA n = 197	TOF MRA n = 197
Reader 1	98.13 (97.61 to 98.65)	85.43 (84.07 to 86.78)
Reader 2	98.51 (98.05 to 98.98)	90.39 (89.26 to 91.51)
Reader 3	98.63 (98.18 to 99.07)	90.42 (89.30 to 91.55)

Population analysed: For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.

Adverse events

Time frame: Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dotarem MRA	1 of 200 (0.5%)	12 of 200 (6%)	Not reported
TOF MRA	0 of 200 (0%)	0 of 200 (0%)	Not reported
Computerized Tomography Angiography (CTA)	2 of 200 (1%)	7 of 200 (3.5%)	Not reported
Patients Discontinued Without Dotarem Administration	1 of 22 (4.5%)	2 of 22 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
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.

Pierre DESCHE, MD 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 3 study testing Dotarem and TOF MRA in people with Cerebral Arterial Diseases, run by Guerbet at 1 site in United States.

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 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 16 Jun 2016. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 Aug 2015). 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?

Technical Failure Rate (time frame: 2 - 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01010932.

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 16 Jun 2016.