Image EvaluationFireflyNCT02232009

Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

A study testing 3.0 T Neonatal MRI Scanner in people with Image Evaluation, run by GE Healthcare at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and… Read more about this study

Who is it for?: Ages Up to 2 years
Conditions the study is for: Image Evaluation
What is being tested?: 3.0 T Neonatal MRI Scanner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 7 May 2015to 30 Nov 2016
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 Up to 2 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subjects will be included that are:
Currently admitted for treatment or observation at the investigational site at the time of enrollment;
In the weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg );
Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age);
Able to safely undergo an MRI scan, as determined by the site's co-investigator neonatologist or medically qualified delegate;
Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;

Show all 9Show fewer

Are of appropriate size and shape to fit into the bore of the magnet, inclusive of all monitoring equipment, if any, necessary for the subject's routine clinical care:
Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).
Maximum length (head-to-foot measurement) less than sixty (60) cm. -

Who cannot join

Subjects will be excluded that:
Have parent(s), guardian(s), or legally authorized representative(s) that require that they accompany the subject into the MR environment that have contraindications to the MR environment or would otherwise be put at undue risk or discomfort, as determined by the investigators;
Require any non-removable medical devices that are not compatible with MR scanning (labeled as MR Unsafe, MR condition for which the scanning conditions are not met, or no MR safety labeling) that may pose hazards in the MR scanning or MR environment, in the opinion of the neonatologist co-investigator or medically qualified delegate;
Have other contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the neonatologist co-investigator;
Require any scheduled standard of care procedures that are expected to be adversely impacted by participation in this study, in the opinion of the principal investigator, neonatologist co-investigator, or medically qualified delegate; and
Have been previously enrolled AND undergone any study procedures under the current study protocol (i.e. the same subject cannot undergo study procedures, including swaddling and/or MR scanning, more than once).

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Development of MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

Read the detailed description

This is a two-phase prospective clinical study evaluating the performance and safety of the investigational MRI device for neonates and infants, including:

Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may include hardware and software modifications. These studies are guided by a series of MR scanning procedures defined in sequential Sponsor-provided MR Procedure Documents
Phase 2 - Controlled image and data collection study based on Phase 1 results, in which optimized scan procedure(s) according to MR Procedure Document(s) will be provided at the start of Phase 2 scanning and a fixed hardware and integrated software configuration will be applied for all subjects.

Conditions: Image Evaluation
Being tested: 3.0 T Neonatal MRI Scanner
Keywords: Neonate, Infant

What participants receive

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

3.0 T Neonatal MRI ScannerDevice
Eligible subjects will undergo neonatal MRI scanning procedures.

Study groups in NCT02232009
Study group	Role	What they receive
3.0 T Neonatal Scanner	Other	All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. Receives: Device: 3.0 T Neonatal MRI Scanner

What is being measured

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

Summary Rates of Adverse Events
Safety will be assessed based on the number of Adverse Events.
Measured: 1 Day
Image Diagnostic Quality
Number of subject whose images were rated as Evaluable
Measured: 1 Day

Secondary outcomes (4)

MRI Scan Time
Duration of MRI scan time for each subject
Measured: 1 Day
Overall Experience With Neonatal MR Scanner Device Summary
User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.
Measured: 1 day
Overall Image Quality
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Measured: 1 day
Subject Change in Temperature
Change in temperature (Celsius) per subject.
Measured: 1 Day

Timeline

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

7 May 201530 Nov 2016

First posted4 Sep 2014 (estimated)
Study start7 May 2015
Primary completion30 Nov 2016
Study completion30 Nov 2016

Why it stopped: Slow/low enrollment

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 Image EvaluationStudies of the same condition, open and under way.
More trials run by GE HealthcareThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02232009
Sponsor's protocol ID: 114-2013-GES-0011
Acronym: Firefly
Status last verified: Jan 2019
First submitted: 15 Aug 2014
Last updated: 30 Jan 2019
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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
ClinicalTrials.gov ID: NCT02232009
Acronym / sponsor ID: Firefly / 114-2013-GES-0011
Conditions: Image Evaluation
Keywords: Neonate, Infant
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow/low enrollment
Enrolment: 9 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: Wellcome Trust
Study start: 7 May 2015 (actual)
Primary completion: 30 Nov 2016 (actual)
Study completion: 30 Nov 2016 (actual)
First posted: 4 Sep 2014 (estimated)
Results: Posted 30 Jan 2019

Clinical summary

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

Detailed description

This is a two-phase prospective clinical study evaluating the performance and safety of the investigational MRI device for neonates and infants, including:

Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may include hardware and software modifications. These studies are guided by a series of MR scanning procedures defined in sequential Sponsor-provided MR Procedure Documents
Phase 2 - Controlled image and data collection study based on Phase 1 results, in which optimized scan procedure(s) according to MR Procedure Document(s) will be provided at the start of Phase 2 scanning and a fixed hardware and integrated software configuration will be applied for all subjects.

Study design

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

Arm	Type	Receives
3.0 T Neonatal Scanner	Other	Device: 3.0 T Neonatal MRI ScannerAll subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.

Who may qualify

Ages: Up to 2 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Currently admitted for treatment or observation at the investigational site at the time of enrollment;
In the weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg );
Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age);
Able to safely undergo an MRI scan, as determined by the site's co-investigator neonatologist or medically qualified delegate;
Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;

Key exclusion criteria (6 listed)

Subjects will be excluded that:

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
3.0 T Neonatal MRI ScannerEligible subjects will undergo neonatal MRI scanning procedures.	Device	3.0 T Neonatal Scanner

Primary outcome

Summary Rates of Adverse Events
Time frame: 1 Day
Safety will be assessed based on the number of Adverse Events.
Image Diagnostic Quality
Time frame: 1 Day
Number of subject whose images were rated as Evaluable

4 secondary outcomes

MRI Scan Time
Time frame: 1 Day
Overall Experience With Neonatal MR Scanner Device Summary
Time frame: 1 day
Overall Image Quality
Time frame: 1 day
Subject Change in Temperature
Time frame: 1 Day

Results and safety

Results posted to the registry on 30 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3.0 T Neonatal Scanner	9	9

Primary outcome: Summary Rates of Adverse Events

Time frame: 1 Day. Number. Unit: number of occurrences

Measure	3.0 T Neonatal Scanner n = 9
Value	1

Primary outcome: Image Diagnostic Quality

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	3.0 T Neonatal Scanner n = 9
Value	9

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3.0 T Neonatal Scanner	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 3.0 T Neonatal MRI Scanner in people with Image Evaluation, run by GE Healthcare 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Jan 2019. 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 30 Jan 2019). 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?

Summary Rates of Adverse Events (time frame: 1 Day). 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 NCT02232009.

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 30 Jan 2019.