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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02085876
Other study ID # HAMZA APJ 2013
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 5, 2014
Last updated March 12, 2014

Study information

Verified date July 2013
Source Centre Hospitalier Universitaire Dijon
Contact Samia HAMZA
Phone 3 80 29 37 50
Email samia.hamza@chu-dijon.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

- The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.

- Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.

- Usual blood samples will be completed by samples for the serum library


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients who have been informed about the research

- Patients with national health insurance cover

- Patients who are overweight (BMI > 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT < 8 times normal values and ALAT > twice normal values) after a complete hepatopathy assessment

- Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT < 8 times normal values and ALAT > twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.

Exclusion Criteria:

- Non-corrected coagulation disorder.

- Patients aged over 80 years

- Patients aged less than 18 years

- Patients without legal protection

- Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight>150kg)

- Patients without national health insurance cover

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
2 additional MRI sequences

An additional blood sample


Locations

Country Name City State
France CHU de DIJON Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant. Baselines No
Secondary To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis. Baselines No
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