Magnetic Resonance Spectroscopy in Acid Sphingomyelinase Deficiency

NCT05904366 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-06-15

No results posted yet for this study

Summary

The goal of this study is to assess the ability of MRI techniques to detect early stages of lipid accumulation in the liver of ASMD patients with the chronic visceral subtype compared to healthy subjects.

Participants will undergo an MRI with MR Spectroscopy (MRS) to measure lipid accumulation (steatosis) and MR Elastography (MRE) to measure liver stiffness (fibrosis).

Conditions

  • Asmd, Visceral Type

Interventions

DIAGNOSTIC_TEST

MR Spectroscopy (MRS)

MR Spectroscopy (MRS)

DIAGNOSTIC_TEST

MR Elastography (MRE)

MR Elastography (MRE) with a device that induces shear waves in the body. This device is placed upon the abdomen of the subject and is hold in place by straps. The device will produce low-frequency vibrations (e.g. 30-60 Hz) which are not painful to the participant. A declaration of conformity and a safety document are provided in the study dossier.

Sponsors & Collaborators

  • Eline C. B. Eskes

    lead OTHER

Principal Investigators

  • Carla EM Hollak, prof dr · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • xx xx xx, xx

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2024-04-01
Completion
2024-09-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904366 on ClinicalTrials.gov