Vascular DiseasesNCT05199792
Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA MRA
An observational study of Vascular Diseases, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show: 1. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Dotarem
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2017to 1 Jan 2020
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: qualifying MRA
Who may be able to join
- Male or female subjects 18-89 years of age
- Suspected or diagnosed vascular disease
- Standard of care carotid, chest, or
- Willingness to undergo 1 research MRA with up to double dose gadoterate meglumine
- Able to complete the MR safety questionnaire
- Able to comprehend and provide informed consent in English
Who cannot join
- • Allergy to gadolinium-containing contrast media
- Chronic, severe kidney disease
- eGFR < 60mL/min/1.73m2
- Acute kidney injury
- Kidney or liver transplant within 8 weeks
- Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
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- Pregnant or breastfeeding women
- Adults unable to consent
- Individual who are not yet adults
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA
The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show:
- Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol.
- Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.
Read the detailed description
In this study, we will assess the image quality and accuracy of MRA studies acquired using these two contrast agents. In the cases where Digital Subtraction Angiography (DSA) or CT angiography images are available, the results of the study using both contrast agents will be compared to the DSA or CTA findings. All MRA images will be assessed independently by two readers. The readers will be blinded to the clinical symptoms, contrast agent and DSA/CTA results. A five-level system rating for image quality of each arterial segment will be used (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis suspected but not established, 3 = fair quality with established diagnosis, 4=good quality with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent quality image information). Vascular lesions will also be graded on a 1-5 scale. Vessel segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2) mild (<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total occlusion.
Grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.
- Conditions
- Vascular Diseases
- Being tested
- Dotarem
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DotaremDiagnostic test
(Dotarem) (0.4 ml/kg (0.2 mmol/kg))
| Study group | Role | What they receive |
|---|---|---|
| 2x dose of Dotarem | qualifying MRA Receives: Diagnostic Test: Dotarem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of MRA image quality
assess the image quality of MRA studies acquired using these two contrast
Measured: 18 months
Secondary outcomes (1)
Assessment of MRA accuracy
Assess the accuracy of MRA studies acquired using these two contrast
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start2 Jun 2017
- Primary completion31 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Carr, Northwestern University
- Investigators
- James Carr, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199792
- Sponsor's protocol ID
- STU00205041
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.
PubMed 12732691Seeger A, Kramer U, Fenchel M, Grimm F, Bretschneider C, Doring J, Klumpp B, Tepe G, Rittig K, Seidensticker PR, Claussen CD, Miller S. Comparison between a linear versus a macrocyclic contrast agent for whole body MR angiography in a clinical routine setting. J Cardiovasc Magn Reson. 2008 Dec 30;10(1):63. doi: 10.1186/1532-429X-10-63.
PubMed 19116027
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA
- ClinicalTrials.gov ID
- NCT05199792
- Acronym / sponsor ID
- STU00205041
- Conditions
- Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 20 Jan 2022 (actual)
- 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.
The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show:
- Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol.
- Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.
Detailed description
In this study, we will assess the image quality and accuracy of MRA studies acquired using these two contrast agents. In the cases where Digital Subtraction Angiography (DSA) or CT angiography images are available, the results of the study using both contrast agents will be compared to the DSA or CTA findings. All MRA images will be assessed independently by two readers. The readers will be blinded to the clinical symptoms, contrast agent and DSA/CTA results. A five-level system rating for image quality of each arterial segment will be used (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis suspected but not established, 3 = fair quality with established diagnosis, 4=good quality with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent quality image information). Vascular lesions will also be graded on a 1-5 scale. Vessel segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2) mild (<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total occlusion.
Grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2x dose of Dotarem | – | Diagnostic Test: Dotaremqualifying MRA |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- qualifying MRA
Key inclusion criteria (6 listed)
- Male or female subjects 18-89 years of age
- Suspected or diagnosed vascular disease
- Standard of care carotid, chest, or
- Willingness to undergo 1 research MRA with up to double dose gadoterate meglumine
- Able to complete the MR safety questionnaire
Key exclusion criteria (10 listed)
- • Allergy to gadolinium-containing contrast media
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 |
|---|---|---|
| Dotarem(Dotarem) (0.4 ml/kg (0.2 mmol/kg)) | Diagnostic test | 2x dose of Dotarem |
Primary outcome
Assessment of MRA image quality
Time frame: 18 months
assess the image quality of MRA studies acquired using these two contrast
1 secondary outcome
Assessment of MRA accuracy
Time frame: 18 months
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 20 Jan 2022.
- Background: PubMed 12732691Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.
- Results publication: PubMed 19116027Seeger A, Kramer U, Fenchel M, Grimm F, Bretschneider C, Doring J, Klumpp B, Tepe G, Rittig K, Seidensticker PR, Claussen CD, Miller S. Comparison between a linear versus a macrocyclic contrast agent for whole body MR angiography in a clinical routine setting. J Cardiovasc Magn Reson. 2008 Dec 30;10(1):63. doi: 10.1186/1532-429X-10-63.
- Individual participant dataSharing planned: No
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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.
James Carr principal investigator
Northwestern University
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 Vascular Diseases, run by Northwestern University 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 6 inclusion and 10 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 20 Jan 2022. 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.
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?
Assessment of MRA image quality (time frame: 18 months). 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 NCT05199792, which also lists 2 linked publications.
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 20 Jan 2022.