Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: MRI calibration

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raluca PAIS, MD; Phone Number: +33(0)1.42.16.55.45; Email: raluca.pais@aphp.fr
• Study Contact Backup: Name: Nadjia KACHENOURA, PhD; Phone Number: 01.44.27.91.16; Email: nadjia.kachenoura@inserm.fr

Study Locations

• France
  • Paris, France, 75013
    • Hopital de la Pitie Salpetriere
    • Contact: Zohra ABBOU, Msc; Email: zohra.abbou@aphp.fr
    • Contact: Khaoula BOUAZIZI, PhD; Email: k.bouazizi@ihuican.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: healthy volunteers	Other: MRI calibration; Non-injected thoracic aorta MRI calibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parametric measurement of thoracic aorta values of normal subjects	Thoracic aorta values measured by MRI	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quantitative fibrosis within the aortic wall (%)	24 months
Quantitative fat within the aortic wall (%)	24 months
Quantitative periaortic fat (g and g/m², when indexed to BSA)	24 months
ROC metrics will be used to compare the various sequences (%)	24 months
Quantitative flow values within the different aortic segments and the main branches (mL)	24 months
Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers	24 months
Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)	24 months
Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Raluca PAIS, MD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: MRI; biomarkers; thoracic aorta; acquisition calibration
• Other Study ID Numbers: APHP211541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No