Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05218460
Other study ID # 2021-A00243-38
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 23, 2022
Est. completion date May 23, 2027

Study information

Verified date September 2022
Source Central Hospital, Nancy, France
Contact Damien MANDRY, MD, PhD
Phone +33383154202
Email d.mandry@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date May 23, 2027
Est. primary completion date May 23, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for all subjects : - to be over 18 year-old, - to be enrolled in a social security plan, - to have underwent a pre-inclusion medical examination, - to give a written consent. Inclusion Criteria for volunteers with pathology : - person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...). Exclusion Criteria for all subjects : - any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ), - subject under a measure of legal protection, - Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI examination
All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.

Locations

Country Name City State
France CHRU de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Image quality based on standard imaging quality criteria The image quality will be appreciated visually at least by a radiologist or a researcher. 6 months after the last inclusion
Primary Signal quality based on standard signal quality criteria The signal quality will be appreciated visually at least by a radiologist or a researcher. 6 months after the last inclusion
Secondary Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation. ignal to Noise Ratio will be measured in arbitrary units. 6 months after the last inclusion
Secondary Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation. Contrast to Noise Ratio will be measured in arbitrary units. 6 months after the last inclusion
Secondary Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation. Absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale (1 to 5 ; 1 is the worst score and 5 is the better score). 6 months after the last inclusion
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1