A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT06920004
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT07121985
The aim of this study is to assess disease activity in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Guillain-Barré Syndrome (GBS) using multispectral optoacoustic tomography (MSOT).
The currently available diagnostic procedures for CIDP and GBS do not allow for a clear distinction between remission and active disease and show limitations in sensitivity and specificity during acute diagnostics. This can lead to delayed diagnosis, which is crucial for timely initiation of therapy and, consequently, for a better prognosis. Long-term therapy management is also challenging, as objective parameters for assessing therapeutic success are largely lacking.
MSOT can detect inflammation through the measurement of hemoglobin, a method that our research group has already successfully demonstrated in patients with chronic inflammatory bowel diseases (Knieling, NEJM 2017). The use of MSOT could therefore also be applied to nerve inflammation, allowing for earlier detection of inflammation and nerve damage and contributing to timely treatment of patients.
For nerve imaging, a CE-certified MSOT device from iThera Medical is available at the Pediatric Clinic in Erlangen. In addition, a non-CE-certified device with lower laser power is available, which can be used for bedside examinations.
The arm nerves will be examined in three cohorts, which will be compared with each other and with standard diagnostics (blood tests, electrophysiology, conventional ultrasound).
Each cohort will include ten healthy control subjects, ten patients with CIDP, and ten patients with GBS.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient Cohort(s):
Inclusion criteria
Control Cohort:
Exclusion criteria
Time frame: Single time point
Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.
Time frame: Single time point
Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves
Time frame: Single time point
Ultrasound-based Doppler signal in the measured nerves
Time frame: Single time point
Ultrasound-based dimensional measurements of the respective nerve.
Time frame: Single time point
Assessment of clinical scores (MRC, NIS) for correlation with imaging data.
Time frame: Single time point
Unmixed photoacoustic lipid signal in the measured nerves
Time frame: Single time point
Unmixed photoacoustic water signal in the measured nerves
Time frame: Single time point
Unmixed photoacoustic collagen signal in the measured nerves
Contact information is provided by the study sponsor or research team.
Adrian Bühler, M.Sc.
CONTACT
Felix Wachter, Dr. med.
CONTACT
University of Erlangen-Nürnberg Medical School
Other
Acronym: MIND
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