CIDP POEMS syndrome Healthy volunteers
Conditions
Interventions
contrast media administration (ProHance or Magnescope)
D003287
Sponsors
Sugiyama Atsuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions are eligible 1) Patients diagnosed with CIDP or POEMS syndrome. 2) Patients who have not started initial treatment after disease onset or before starting additional treatment after relapse. 3) Patients 20 years of age or older. 4) Patients who have given their consent based on their free will Healthy individuals who met all of the following conditions are eligible 1) Healthy subjects between the ages of 20 and 65 years (without autoimmune, neurological, or chronic diseases, and without abnormal neurological findings on neurological examination) 2) Subjects who have given their consent based on their free will
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions are not eligible for the study 1) Those who are unable to perform contrast-enhanced MRI, such as those who have a pacemaker or other MRI-incompatible device implanted in the body, claustrophobia, pregnancy, or active asthma. 2) Patients who have had allergic reactions to contrast media in the past 3) Patients with renal dysfunction: estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 4) Other subjects who are judged to be unsuitable for the study by the investigator(s). healthy subjects 5) Subjects with a history of or currently suffering from clinically problematic neurological, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or mental disorders 6) Patients with a history of serious head and spinal cord trauma, gastrointestinal bleeding within 3 months, urinary tract bleeding, or major surgery. 7) Patients who are judged to be inadequate for screening tests (blood tests, blood pressure, etc.) 8) Participated in a clinical trial of a drug containing a new active ingredient within 4 months or any other clinical trial within 3 months and received an investigational drug 9) Patients who are taking any medications, including over-the-counter medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of Ki (calculated using MRI) for the presence of BNB disruption evaluated based on Qalb is assessed by calculating the AUC of ROC analysis, and sensitivity and specificity are calculated using the optimal cutoff values set by ROC analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Tolerability of contrast administration to subjects (2) Correlation between Ki and Qalb (3) Intergroup comparison of Ki (4) Correlation between CSF cell count, blood and CSF cytokines and Ki (5) Changes in Ki before and after treatment | — |
Contacts
Public ContactAtsuhiko Sugiyama
Graduate School of Medicine, Chiba University
Outcome results
None listed