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

March 31, 2023 updated by: Zunsong Wang, Qianfoshan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Tacrolimus for the treatment of IMN
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.
Drug: Tacrolimus for the treatment of IMN
Remission after tacrolimus treatment of IMN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microhyperspectral image of a transrenal specimen
Time Frame: 2023.4-2023.12
Microhyperspectral image of a pathological section of the kidney
2023.4-2023.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 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

March 31, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAC-IMN-HSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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