Transient Severe Arterial Phase MotionPhase 4NCT02431598
Eovist vs. Dotarem Healthy Volunteer MRI
A Phase 4 study testing gadoxetate disodium, gadoterate dimeglumine and Saline in people with Transient Severe Arterial Phase Motion, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transient Severe Arterial Phase Motion
- What is being tested?
- gadoxetate disodium, gadoterate dimeglumine and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal renal function (serum eGFR >60)
Who cannot join
- renal impairment
- allergy to gadolinium-based contrast
- metallic implanted devices
- claustrophobia
- pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact
The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.
- Conditions
- Transient Severe Arterial Phase Motion
- Being tested
- gadoxetate disodium, gadoterate dimeglumine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadoxetate disodiumDrug
Also called Eovist
gadoterate dimeglumineDrug
Also called Dotarem
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Eovist (gadoxetate disodium) | Active comparator | While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. Receives: Drug: gadoxetate disodium |
| Dotarem (gadoterate dimeglumine) | Active comparator | While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. Receives: Drug: gadoterate dimeglumine |
| Saline | Active comparator | While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
Measured: following contrast administration, up to 5 minutes
Subject-reported Dyspnea, as Measured by Questionnaire Responses
After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.
Measured: following contrast administration, up to 5 minutes
Secondary outcomes (4)
O2 Saturation Following Contrast Administration
Measured: following contrast administration, up to 5 minutes
Heart Rate Following Contrast Injection
Heart rate following contrast injection
Measured: following contrast administration, up to 5 minutes
Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging
Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test.
Measured: following contrast administration, up to 5 minutes
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
- no motion artifact
- minimal motion artifact
- moderate motion artifact
- severe motion artifact
- extensive motion artifact
Measured: following contrast administration, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
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 Transient Severe Arterial Phase MotionStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Mustafa Bashir, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431598
- Sponsor's protocol ID
- Pro00059192
- Status last verified
- Mar 2017
- First submitted
- 28 Apr 2015
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact
- ClinicalTrials.gov ID
- NCT02431598
- Acronym / sponsor ID
- Pro00059192
- Conditions
- Transient Severe Arterial Phase Motion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego, University of Wisconsin, Madison
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 14 Apr 2017
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 evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eovist (gadoxetate disodium) | Active comparator | Drug: gadoxetate disodiumWhile in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. |
| Dotarem (gadoterate dimeglumine) | Active comparator | Drug: gadoterate dimeglumineWhile in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. |
| Saline | Active comparator | Drug: SalineWhile in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normal renal function (serum eGFR >60)
Key exclusion criteria (5 listed)
- renal impairment
- allergy to gadolinium-based contrast
- metallic implanted devices
- claustrophobia
- pregnant and lactating females
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 |
|---|---|---|
| gadoxetate disodiumAlso: Eovist | Drug | Eovist (gadoxetate disodium) |
| gadoterate dimeglumineAlso: Dotarem | Drug | Dotarem (gadoterate dimeglumine) |
| Saline | Drug | Saline |
Primary outcome
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
Time frame: following contrast administration, up to 5 minutes
Subject-reported Dyspnea, as Measured by Questionnaire Responses
Time frame: following contrast administration, up to 5 minutes
After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.
4 secondary outcomes
O2 Saturation Following Contrast Administration
Time frame: following contrast administration, up to 5 minutes
Heart Rate Following Contrast Injection
Time frame: following contrast administration, up to 5 minutes
Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging
Time frame: following contrast administration, up to 5 minutes
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
Time frame: following contrast administration, up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Mustafa Bashir, MD principal investigator
Duke University
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 gadoxetate disodium, gadoterate dimeglumine and Saline in people with Transient Severe Arterial Phase Motion, run by Duke 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 1 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 Apr 2017. 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 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 14 Apr 2017). 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?
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath (time frame: following contrast administration, up to 5 minutes). 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 Apr 2017.