Study on the Application of Hyperspectral Imaging Technique in CTX Treatment of IMN

Investigators propose hyperspectral imaging analysis as a method to distinguish the efficacy of hormone-combined cyclophosphamide therapy for PMN, and classify sensitive and insensitive patients treated with hormone-combined cyclophosphamide regimen. A variety of machine learning models were used to prove that hyperspectral imaging technology could assist patients in selecting the optimal treatment plan, and further explore the predictive indicators of PMN treatment effect.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Membranous Nephropathy; Cyclophosphamide; Hyperspectral Imaging
• Intervention / Treatment: Device: Microscopic hyperspectral imaging system

Detailed Description

Renal puncture pathological sections from patients with nephropathy. ENVI Classic software was used to process the hyperspectral images and delineate the region of interest, and the one-dimensional spectral data of each pixel in each region were derived. Machine learning and deep learning methods were used to analyze the characteristics of hyperspectral data and classify them.

The data of the previous study came from the Department of Pathology and Nephrology of Qianfoshan Hospital in Shandong Province. Under the light microscope, electron microscope and immunofluorescence microscope, the pathological types of glomerular diseases in patients with proteinuria were identified. By scanning the corresponding patient's H&E stained pathological sections, the hyperspectral microscopic images were classified by machine learning and deep learning methods, and the classification accuracy was greater than 85%. It was concluded that hyperspectral imaging technology can be used as a non-invasive diagnostic method to predict treatment response.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Wang Zunsong, doctor; Phone Number: 18660190175; Email: wzsong3@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with clinical manifestations of massive albuminuria and confirmed by renal biopsy as idiopathic membranous nephropathy.

Description

Inclusion Criteria:

• Over 18 years old;
• Patients with idiopathic membranous 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:

• 1.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;
• Patients with follow-up time less than 6 months, incomplete data or missed diagnosis;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CTX group in remission; The patients with idiopathic membranous nephropathy were divided into two groups: the group in remission and the group without remission after the application of cyclophosphamide. The pathological sections of the kidneys of the two groups were observed by microhyperspectral imaging system, and the differences between the two groups of patients under the spectrum were analyzed.	Device: Microscopic hyperspectral imaging system; CTX for idiopathic membranous nephropathy
CTX group without remission; The patients with idiopathic membranous nephropathy were divided into two groups: the group in remission and the group without remission after the application of cyclophosphamide. The pathological sections of the kidneys of the two groups were observed by microhyperspectral imaging system, and the differences between the two groups of patients under the spectrum were analyzed.	Device: Microscopic hyperspectral imaging system; CTX for idiopathic membranous nephropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microhyperspectral image of a transrenal specimen	The microscopic hyperspectral images could accurately distinguish the remission group from the remission group with an accuracy of more than 80%	2023.3-2023.12

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 25, 2023
• Primary Completion (Anticipated): July 20, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: April 29, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Glomerulonephritis, Membranous
• Other Study ID Numbers: HSI in CTX treaatment of IMN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No