Hyperspectral ImagingNCT05850845
Study on the Application of Hyperspectral Imaging Technique in CTX Treatment of IMN
An observational study of Hyperspectral Imaging and Idiopathic Membranous Nephropathy, run by Qianfoshan Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hyperspectral Imaging, Idiopathic Membranous Nephropathy, Cyclophosphamide
- What is being tested?
- Microscopic hyperspectral imaging system
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical manifestations of massive albuminuria and confirmed by renal biopsy as idiopathic membranous nephropathy.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Microscopic hyperspectral imaging system
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic hyperspectral imaging systemDevice
CTX for idiopathic membranous nephropathy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Microscopic hyperspectral imaging system | |
| 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. Receives: Device: Microscopic hyperspectral imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 2023.3-2023.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start25 Jun 2023 (estimated)
- Primary completion20 Jul 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperspectral ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850845
- Sponsor's protocol ID
- HSI in CTX treaatment of IMN
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of Hyperspectral Imaging Technique in CTX Treatment of IMN
- ClinicalTrials.gov ID
- NCT05850845
- Acronym / sponsor ID
- HSI in CTX treaatment of IMN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 25 Jun 2023 (estimated)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTX group in remission | – | Device: Microscopic hyperspectral imaging systemThe 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. |
| CTX group without remission | – | Device: Microscopic hyperspectral imaging systemThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical manifestations of massive albuminuria and confirmed by renal biopsy as idiopathic membranous nephropathy.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microscopic hyperspectral imaging systemCTX for idiopathic membranous nephropathy | Device | CTX group in remission, CTX group without remission |
Primary outcome
Microhyperspectral image of a transrenal specimen
Time frame: 2023.3-2023.12
The microscopic hyperspectral images could accurately distinguish the remission group from the remission group with an accuracy of more than 80%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperspectral Imaging and Idiopathic Membranous Nephropathy, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Zunsong, doctor (18660190175, wzsong3@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microhyperspectral image of a transrenal specimen (time frame: 2023.3-2023.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.