Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases

Diabetic Nephropathies Clinical Trial

Official title:

Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05797051
• Other study ID #: liquid biopsy-glomerulopathy
• Status: Not yet recruiting
• Start date: May 30, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2023
• Source: Qianfoshan Hospital
• Contact: Wang Zongsong
• Phone: 18660190175
• Email: wzsong3[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Morning urine samples of patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and minimal degenerative nephropathy confirmed by renal needle biopsy in our hospital from November 2020 to January 2022 were collected. By scanning the morning urine samples of corresponding patients with microhyperspectral imager, machine learning and deep learning were used to classify microhyperspectral images, and the classification accuracy was greater than 85%. Thus, hyperspectral imaging technology could be used as a non-invasive diagnostic means to assist the diagnosis of glomerular diseases.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Over 18 years old;
• Patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, minimal change nephropathy confirmed by renal biopsy;
• Had not received hormone and/or immunosuppressive therapy before renal biopsy;
• Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

Exclusion Criteria:

• There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc.;
• Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
• Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
• Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
• Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Glomerulonephritis
• Glomerulonephritis, IGA
• Glomerulonephritis, Membranous
• Nephrosis
• Nephrosis, Lipoid

Intervention

Diagnostic Test:
• Microscopic hyperspectral imaging system
Microscopic hyperspectral imaging system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microhyperspectral image of urine specimen	Microhyperspectral images of urine samples from patients with four different glomerular diseases before treatment	2023.4-2023.10