Study on the Application of Hyperspectral Imaging Technique in the Treatment of IMN by TAC

NCT ID: NCT05797038

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2023-12-30

Brief Summary

We propose hyperspectral imaging analysis as a method to identify the efficacy of hormone-tacrolimus therapy for PMN, and to classify sensitive and insensitive patients treated with hormone-tacrolimus 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.

Detailed Description

Renal biopsy slides of patients with idiopathic membranous nephropathy diagnosed by renal biopsy in our hospital from February 2016 to February 2022 were collected. ENVI Classic software was used to process the hyperspectral images and delineate the region of interest. 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.

Conditions

Idiopathic Membranous Nephropathy; Tacrolimus; Hyperspectral Imaging

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

TAC group in remission

The patients with idiopathic membranous nephropathy were divided into two groups, the remission group and the non-remission group after the application of tacrolimus. The renal pathological sections of the two groups were observed by microhyperspectral imaging system, and the differences in the spectra of the two groups were analyzed.

Tacrolimus for the treatment of IMN

Intervention Type: DRUG

Remission after tacrolimus treatment of IMN

TAC group without remission

The patients with idiopathic membranous nephropathy were divided into two groups, the remission group and the non-remission group after the application of tacrolimus. The renal pathological sections of the two groups were observed by microhyperspectral imaging system, and the differences in the spectra of the two groups were analyzed.

Tacrolimus for the treatment of IMN

Intervention Type: DRUG

Remission after tacrolimus treatment of IMN

Interventions

Tacrolimus for the treatment of IMN

Remission after tacrolimus treatment of IMN

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zunsong Wang

Qianfo Mountain Hospital of Shandong Province

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wang Zongsong

Role: CONTACT

wzsong3@163.com

18660190175

Other Identifiers

TAC-IMN-HSI

Identifier Type: -

Identifier Source: org_study_id