Healthy VolunteersSEQUOIANCT05545410
Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers
A study testing MRI calibration in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRI calibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2022to Nov 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject aged between 20 and 35 or between 50 and 70 (limits included)
- BMI < 30 kg/m²
- Asymptomatic subject
- Having given informed, free and written consent
- Affiliated to a French social security scheme or entitled
Who cannot join
- Contraindication to MRI (claustrophobia, presence of a metallic foreign body)
- Pregnant or breastfeeding woman
- Known cardiac pathology
- Personal cardiovascular history
- Person deprived of liberty by court decision or benefiting from legal protection (under guardianship or curatorship)
- Abuse of alcohol or narcotics
- Subject under AME
- Participation in another interventional research involving the human person or being in the exclusion period at the end of a previous research involving the human person
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Pitié Salpêtrière
Paris, 75013
Zohra ABBOU, Msc, zohra.abbou@aphp.fr
Khaoula BOUAZIZI, PhD, k.bouazizi@ihuican.org
About this study
Official title: Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)
The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.
Read the detailed description
This Magnetic Resonance imaging study of the thoracic aorta aims to: 1- enhance patient comfort during the examination, shorten appointment waiting times and overall reduce MRI cost, and 2- provide a reliable diagnosis and risk assessment of aorta-related diseases occurring in hypertension, obesity or diabetes but also throughout normal aging.
The impact of MRI acquisition innovations on the measurement of biomarkers that are extracted from image post-processing software and therein on disease characterization (normal values, severity thresholds, etc.) must be systematically reevaluated. More specifically, the investigators design image acquisition and automated image processing methods to reduce operator variability. This study will optimize thoracic aortic MRI acquisition sequences for the quantification of diagnostic-assisting biomarkers in a healthy population.
- Conditions
- Healthy Volunteers
- Being tested
- MRI calibration
- Keywords
- thoracic aorta, MRI, acquisition calibration, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI calibrationOther
Non-injected thoracic aorta MRI calibration
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Other | Not described Receives: Other: MRI calibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parametric measurement of thoracic aorta values of normal subjects
Thoracic aorta values measured by MRI
Measured: 24 months
Secondary outcomes (8)
Quantitative fibrosis within the aortic wall (%)
Measured: 24 months
Quantitative fat within the aortic wall (%)
Measured: 24 months
Quantitative periaortic fat (g and g/m², when indexed to BSA)
Measured: 24 months
ROC metrics will be used to compare the various sequences (%)
Measured: 24 months
Quantitative flow values within the different aortic segments and the main branches (mL)
Measured: 24 months
Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers
Measured: 24 months
Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)
Measured: 24 months
Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raluca PAIS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545410
- Sponsor's protocol ID
- APHP211541
- Acronym
- SEQUOIA
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)
- ClinicalTrials.gov ID
- NCT05545410
- Acronym / sponsor ID
- SEQUOIA / APHP211541
- Conditions
- Healthy Volunteers
- Keywords
- thoracic aorta, MRI, acquisition calibration, biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 19 Sep 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 main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.
Detailed description
This Magnetic Resonance imaging study of the thoracic aorta aims to: 1- enhance patient comfort during the examination, shorten appointment waiting times and overall reduce MRI cost, and 2- provide a reliable diagnosis and risk assessment of aorta-related diseases occurring in hypertension, obesity or diabetes but also throughout normal aging.
The impact of MRI acquisition innovations on the measurement of biomarkers that are extracted from image post-processing software and therein on disease characterization (normal values, severity thresholds, etc.) must be systematically reevaluated. More specifically, the investigators design image acquisition and automated image processing methods to reduce operator variability. This study will optimize thoracic aortic MRI acquisition sequences for the quantification of diagnostic-assisting biomarkers in a healthy population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Other: MRI calibration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject aged between 20 and 35 or between 50 and 70 (limits included)
- BMI < 30 kg/m²
- Asymptomatic subject
- Having given informed, free and written consent
- Affiliated to a French social security scheme or entitled
Key exclusion criteria (8 listed)
- Contraindication to MRI (claustrophobia, presence of a metallic foreign body)
- Pregnant or breastfeeding woman
- Known cardiac pathology
- Personal cardiovascular history
- Person deprived of liberty by court decision or benefiting from legal protection (under guardianship or curatorship)
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 |
|---|---|---|
| MRI calibrationNon-injected thoracic aorta MRI calibration | Other | healthy volunteers |
Primary outcome
Parametric measurement of thoracic aorta values of normal subjects
Time frame: 24 months
Thoracic aorta values measured by MRI
8 secondary outcomes
Quantitative fibrosis within the aortic wall (%)
Time frame: 24 months
Quantitative fat within the aortic wall (%)
Time frame: 24 months
Quantitative periaortic fat (g and g/m², when indexed to BSA)
Time frame: 24 months
ROC metrics will be used to compare the various sequences (%)
Time frame: 24 months
Quantitative flow values within the different aortic segments and the main branches (mL)
Time frame: 24 months
Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers
Time frame: 24 months
Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)
Time frame: 24 months
Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Raluca PAIS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI calibration in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 8 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 19 Sep 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raluca PAIS, MD (+33(0)1.42.16.55.45, raluca.pais@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parametric measurement of thoracic aorta values of normal subjects (time frame: 24 months). 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 19 Sep 2022.