Abdominal MRINCT02434471

Single Breath Hold Abdominal MRI

A study testing Respiratory-triggered T1w DISCO LAVA in people with Abdominal MRI, run by Duke University 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 purpose of this study is to evaluate a single breath hold abdominal MRI protocol and compare the image quality of respiratory triggered 3D T1-weighted images against conventional breath hold images. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal MRI
What is being tested?: Respiratory-triggered T1w DISCO LAVA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 12 Jan 2016to 1 Jun 2017
Phase: Interventional
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

undergoing abdominal MRI

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

United States1 site

DukeUMC
Durham, North Carolina, 27710

Other trials in United States

About this study

Conditions: Abdominal MRI
Being tested: Respiratory-triggered T1w DISCO LAVA

What participants receive

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

Respiratory-triggered T1w DISCO LAVADevice
The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.
1. Respiratory-triggered T1w DISCO LAVA precontrast
2. Respiratory-triggered T1w DISCO LAVA in the portal venous phase
3. Respiratory-triggered T1w DISCO LAVA in the equilibrium phase

Study groups in NCT02434471
Study group	Role	What they receive
Breath hold Liver Acquisition with Volume Acquisition (LAVA)	No intervention	Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.
Respiratory-triggered T1w DISCO LAVA	Active comparator	The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required. Receives: Device: Respiratory-triggered T1w DISCO LAVA

What is being measured

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

Motion Artifact Scores
Three investigators will independently evaluate MRI examinations. They will assign motion scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no motion artifact; 2 = minimal motion artifact, no effect on diagnostic quality; 3 = moderate motion artifact with some, but not severe, effect on diagnostic quality; 4 = severe motion artifact, images degraded but interpretable; and 5 = extensive motion artifact, images nondiagnostic.
Measured: During MRI, up to 60 minutes
Noise Scores
Three investigators will independently evaluate MRI examinations. They will assign noise scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no noise artifact; 2 = minimal noise artifact, no effect on diagnostic quality; 3 = moderate noise artifact with some, but not severe, effect on diagnostic quality; 4 = severe noise artifact, images degraded but interpretable; and 5 = severe noise artifact, images nondiagnostic.
Measured: During MRI, up to 60 minutes

Timeline

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

12 Jan 20161 Jun 2017

First posted5 May 2015 (estimated)
Study start12 Jan 2016
Primary completion1 Jun 2017
Study completion1 Jun 2017

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 Abdominal MRIStudies 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 N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02434471
Sponsor's protocol ID: Pro00061735
Status last verified: May 2018
First submitted: 28 Apr 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

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?

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All Abdominal MRI trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Breath Hold Abdominal MRI
ClinicalTrials.gov ID: NCT02434471
Acronym / sponsor ID: Pro00061735
Conditions: Abdominal MRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 12 Jan 2016 (actual)
Primary completion: 1 Jun 2017 (actual)
Study completion: 1 Jun 2017 (actual)
First posted: 5 May 2015 (estimated)
Results: Posted 31 May 2018

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Breath hold Liver Acquisition with Volume Acquisition (LAVA)	No intervention	–Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.
Respiratory-triggered T1w DISCO LAVA	Active comparator	Device: Respiratory-triggered T1w DISCO LAVAThe study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.

Who may qualify

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

Key inclusion criteria (1 listed)

undergoing abdominal MRI

Key exclusion criteria (1 listed)

none

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
Respiratory-triggered T1w DISCO LAVAThe study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required. 1. Respiratory-triggered T1w DISCO LAVA precontrast 2. Respiratory-triggered T1w DISCO LAVA in the portal venous phase 3. Respiratory-triggered T1w DISCO LAVA in the equilibrium phase	Device	Respiratory-triggered T1w DISCO LAVA

Primary outcome

Motion Artifact Scores
Time frame: During MRI, up to 60 minutes
Three investigators will independently evaluate MRI examinations. They will assign motion scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no motion artifact; 2 = minimal motion artifact, no effect on diagnostic quality; 3 = moderate motion artifact with some, but not severe, effect on diagnostic quality; 4 = severe motion artifact, images degraded but interpretable; and 5 = extensive motion artifact, images nondiagnostic.
Noise Scores
Time frame: During MRI, up to 60 minutes
Three investigators will independently evaluate MRI examinations. They will assign noise scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no noise artifact; 2 = minimal noise artifact, no effect on diagnostic quality; 3 = moderate noise artifact with some, but not severe, effect on diagnostic quality; 4 = severe noise artifact, images degraded but interpretable; and 5 = severe noise artifact, images nondiagnostic.

Results and safety

Results posted to the registry on 31 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Breath-held LAVA Then Respiratory Triggered Exams	34	25

Primary outcome: Motion Artifact Scores

Time frame: During MRI, up to 60 minutes. Mean (Standard Deviation). Unit: scores on a scale

Measure	Breath Hold Liver Acquisition With Volume Acquisition (LAVA) n = 25	Respiratory-triggered T1w DISCO LAVA n = 25
Value	1.8 (1.0)	2.4 (0.9)

Breath Hold Liver Acquisition With Volume Acquisition (LAVA) vs Respiratory-triggered T1w DISCO LAVA: Mean Difference (Final Values): 0.6, p <0.001, Mixed Models Analysis

Population analysed: The same 25 subjects were used in both groups.

Primary outcome: Noise Scores

Time frame: During MRI, up to 60 minutes. Mean (Standard Deviation). Unit: scores on a scale

Measure	Breath Hold Liver Acquisition With Volume Acquisition (LAVA) n = 25	Respiratory-triggered T1w DISCO LAVA n = 25
Value	1.7 (0.6)	1.8 (0.7)

Breath Hold Liver Acquisition With Volume Acquisition (LAVA) vs Respiratory-triggered T1w DISCO LAVA: Mean Difference (Final Values): 0.1, p = 0.83, Mixed Models Analysis

Population analysed: The same 25 subjects were used for each group.

Adverse events

Time frame: 60 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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.

Mustafa R 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 study testing Respiratory-triggered T1w DISCO LAVA in people with Abdominal MRI, 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 1 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 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 31 May 2018). 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?

Motion Artifact Scores (time frame: During MRI, up to 60 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?

On the ClinicalTrials.gov record for NCT02434471.

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 Jul 2018.