Inner Ear ; Meniere's Disease; ImagingFAST-HYDROPSNCT04949321
Acceleration of the Kinetics of Diffusion of Gadolinium in the Perilymphatic Structures of the Inner Ear.
A study testing Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL) in people with Inner Ear ; Meniere's Disease; Imaging, run by University Hospital, Grenoble.
Trial summary
To determine the optimal delay after Gadolinium injection to analysis inner ear structures as measured by repeated MR 3D-FLAIR Weighted Imaging. We hypothesize that the endolymphatic structures can be distinguished earlier than 4 hours after contrast media injection. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inner Ear ; Meniere's Disease; Imaging
- What is being tested?
- Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2021to 31 May 2023
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients minors Patients pregnant Patients on a legal protection regime type guardianship Respiratory pathologies, cardiovascular or renal disorders, neurological diseases Claustrophobia Contraindications to exposure to a magnetic field Contraindications to injecting Gadovist® Other ongoing clinical trials with exclusion period for MRI
Trial locations and contacts
No sites are listed yet.
About this study
To determine the optimal delay after Gadolinium injection to analysis inner ear structures as measured by repeated MR 3D-FLAIR Weighted Imaging. We hypothesize that the endolymphatic structures can be distinguished earlier than 4 hours after contrast media injection.
Read the detailed description
The gadolinium contrast agents are now required to cross the blood-perilymph inner ear barrier after an intravenous administration in order to assess the endolymphatic structures in patients with vertigo or hearing loss, using MRI with delayed acquisition (at least 4 hours between injection and images acquisition).
This technique relies on the glymphatic diffusion of the gadolinium agents (Naganawa et al.,MRM Sci 2017) and has proved to be useful in patients with Meniere's Disease (Naganawa et al., AJNR 2014, Attyé et al., Eur Radiol 2018), Recurrent Peripheral Vestibulopathy (Attye et al., Eur Radiol 2015) or Otosclerosis (Mukaida et al., Otol Neurotol 2015), leading to numerous scientific publications over the last decade. The inner ear perilymph enhancement is particularly important to distinguish the saccule from the utricle, these inner ear structures were recently used to classify with imaging Meniere's Disease patient (Attye et al; European Radiology 2016).
We recently demonstrated in patients (Eliezer et al., J Neuroradiol 2018), comparing the effect of two macrocyclic contrast agents (Gd-DOTA, Dotarem® and Gd-DO3A-butrol, Gadovist®), that the Gd-DO3A-butrol better enhanced inner ear structures that Gd-DOTA, both with qualitative and quantitative analysis, allowing to more accurately diagnose endolymphatic hydrops in Meniere's Disease patients.
We have speculated that the differences in the physiochemical properties of Gd-contrast agents (concentration, relaxivity, osmalality) are determining factors to cross the blood-perilymph barrier.
These properties should allow scanning diseased patients earlier after contrast media administration, the delay between the injection and MRI acquisition being actually a limitation to expand this technique in the clinical setting, particularly with 1.5T magnets, due to the low Signal to Noise Ratio using 3D-FLAIR sequences analysis.
Here, we want to conduct multi-centre prospective clinical and radiological study to determine the optimal timing to explore Meniere's Disease patient after Gadobutrol injection with single dose intravenous administration.
- Conditions
- Inner Ear ; Meniere's Disease; Imaging
- Being tested
- Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)
- Keywords
- Magnetic Resonance Imaging; Contrast Media
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)Other
Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)
| Study group | Role | What they receive |
|---|---|---|
| Gadovist (gadobutrol) / two MRI | Experimental | 60 Meniere's Disease patients and 20 healthy volunteers (sample of 5 volunteers per MRI machine) Receives: Other: Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted visualization of the saccule and utricle on the early MR sequences when compared to the 4-hours MR 3D FLAIR sequence (gold standard).
Qualitative:Visibility/Visual evaulation of the endolymphatic structures (saccule/utricle) on various 3D-FLAIR acquisition
For endolymphatic hydrops analysis, we will use the classification that we have published in European Radiology (Attye et al, Eur Radiol 2016).
Quantitative: T1 mapping: Automatic and manual measurement of the T1 relaxation time values of the endolymph for each MR sequence by drawing ROIs.
Measured: 4 hours
Secondary outcomes (1)
Gadolinium enhancement in basal nuclei as measured by T1 and T2 relaxometry maps.
T1 mapping: Automatic and manual measurement of the T1 relaxation time values of the endolymph for each MR sequence by drawing ROIs.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start31 Jul 2021 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inner Ear ; Meniere's Disease; ImagingStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949321
- Sponsor's protocol ID
- 38RC20.394
- Acronym
- FAST-HYDROPS
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceleration of the Kinetics of Diffusion of Gadolinium in the Perilymphatic Structures of the Inner Ear.
- ClinicalTrials.gov ID
- NCT04949321
- Acronym / sponsor ID
- FAST-HYDROPS / 38RC20.394
- Conditions
- Inner Ear ; Meniere's Disease; Imaging
- Keywords
- Magnetic Resonance Imaging; Contrast Media
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 2 Jul 2021 (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.
To determine the optimal delay after Gadolinium injection to analysis inner ear structures as measured by repeated MR 3D-FLAIR Weighted Imaging. We hypothesize that the endolymphatic structures can be distinguished earlier than 4 hours after contrast media injection.
Detailed description
The gadolinium contrast agents are now required to cross the blood-perilymph inner ear barrier after an intravenous administration in order to assess the endolymphatic structures in patients with vertigo or hearing loss, using MRI with delayed acquisition (at least 4 hours between injection and images acquisition).
This technique relies on the glymphatic diffusion of the gadolinium agents (Naganawa et al.,MRM Sci 2017) and has proved to be useful in patients with Meniere's Disease (Naganawa et al., AJNR 2014, Attyé et al., Eur Radiol 2018), Recurrent Peripheral Vestibulopathy (Attye et al., Eur Radiol 2015) or Otosclerosis (Mukaida et al., Otol Neurotol 2015), leading to numerous scientific publications over the last decade. The inner ear perilymph enhancement is particularly important to distinguish the saccule from the utricle, these inner ear structures were recently used to classify with imaging Meniere's Disease patient (Attye et al; European Radiology 2016).
We recently demonstrated in patients (Eliezer et al., J Neuroradiol 2018), comparing the effect of two macrocyclic contrast agents (Gd-DOTA, Dotarem® and Gd-DO3A-butrol, Gadovist®), that the Gd-DO3A-butrol better enhanced inner ear structures that Gd-DOTA, both with qualitative and quantitative analysis, allowing to more accurately diagnose endolymphatic hydrops in Meniere's Disease patients.
We have speculated that the differences in the physiochemical properties of Gd-contrast agents (concentration, relaxivity, osmalality) are determining factors to cross the blood-perilymph barrier.
These properties should allow scanning diseased patients earlier after contrast media administration, the delay between the injection and MRI acquisition being actually a limitation to expand this technique in the clinical setting, particularly with 1.5T magnets, due to the low Signal to Noise Ratio using 3D-FLAIR sequences analysis.
Here, we want to conduct multi-centre prospective clinical and radiological study to determine the optimal timing to explore Meniere's Disease patient after Gadobutrol injection with single dose intravenous administration.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadovist (gadobutrol) / two MRI | Experimental | Other: Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)60 Meniere's Disease patients and 20 healthy volunteers (sample of 5 volunteers per MRI machine) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients minors Patients pregnant Patients on a legal protection regime type guardianship Respiratory pathologies, cardiovascular or renal disorders, neurological diseases Claustrophobia Contraindications to exposure to a magnetic field Contraindications to injecting Gadovist® Other ongoing clinical trials with exclusion period for MRI
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 |
|---|---|---|
| Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL) | Other | Gadovist (gadobutrol) / two MRI |
Primary outcome
Adapted visualization of the saccule and utricle on the early MR sequences when compared to the 4-hours MR 3D FLAIR sequence (gold standard).
Time frame: 4 hours
Qualitative:Visibility/Visual evaulation of the endolymphatic structures (saccule/utricle) on various 3D-FLAIR acquisition For endolymphatic hydrops analysis, we will use the classification that we have published in European Radiology (Attye et al, Eur Radiol 2016). Quantitative: T1 mapping: Automatic and manual measurement of the T1 relaxation time values of the endolymph for each MR sequence by drawing ROIs.
1 secondary outcome
Gadolinium enhancement in basal nuclei as measured by T1 and T2 relaxometry maps.
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL) in people with Inner Ear ; Meniere's Disease; Imaging, run by University Hospital, Grenoble.
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 0 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud ATTYE, PU (0610770671, aattye@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapted visualization of the saccule and utricle on the early MR sequences when compared to the 4-hours MR 3D FLAIR sequence (gold standard). (time frame: 4 hours). 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 2 Jul 2021.