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临床试验/NCT05797038
NCT05797038尚未招募不适用

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

Qianfoshan Hospital0 个研究点目标入组 40 人开始时间: 2023年4月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Microhyperspectral image of a transrenal specimen

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Tacrolimus for the treatment of IMN (Drug)

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.

干预措施: Tacrolimus for the treatment of IMN (Drug)

结局指标

主要结局

Microhyperspectral image of a transrenal specimen

时间窗: 2023.4-2023.12

Microhyperspectral image of a pathological section of the kidney

次要结局

未报告次要终点

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zunsong Wang

Qianfo Mountain Hospital of Shandong Province

Qianfoshan Hospital

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