Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366529
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-08
Brief Title:
Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction
Sponsor:
Zhen Li
Organization:
Tongji Hospital
Study Overview
Official Title:
Explore the Value of New Magnetic Resonance Technology in Non-invasive Quantitative Assessment of Renal Dysfunction and Renal Fibrosis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis but it is invasive and carries the risk of serious complications and the sampled tissue is only a small part of the kidney which is prone to sampling bias The lack of reliable comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs Therefore the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved
With the continuous development and update of technology imaging provides a new way to non-invasively evaluate renal fibrosis Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status physical properties and molecular properties of the kidney
In recent years in the context of precision medicine artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis It can extract and learn features in images with high throughput make greater use of information in medical images that cannot be recognized by the human eye and achieve disease diagnosis prognosis assessment and efficacy prediction by building models However most of the current research is in the preliminary stage and there are still few studies on the assessment of renal insufficiency and renal fibrosis I believe that with the continuous improvement of algorithms and the optimization of models the progress of radiomics and machine learning will be great To a certain extent it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis
With the continuous development and update of technology imaging provides a new way to non-invasively evaluate renal fibrosis Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status physical properties and molecular properties of the kidney
In recent years in the context of precision medicine artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis It can extract and learn features in images with high throughput make greater use of information in medical images that cannot be recognized by the human eye and achieve disease diagnosis prognosis assessment and efficacy prediction by building models However most of the current research is in the preliminary stage and there are still few studies on the assessment of renal insufficiency and renal fibrosis I believe that with the continuous improvement of algorithms and the optimization of models the progress of radiomics and machine learning will be great To a certain extent it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis
Detailed Description:
Renal insufficiency can be divided into acute kidney injury AKI and chronic kidney disease CKD There are many causes of AKI which are mainly divided into three categories prerenal renal and postrenal according to the anatomical location The incidence rate of AKI is about 3 to 10 and the incidence rate in intensive care units is higher as high as 30 to 60 when AKI patients are seriously ill the mortality rate is higher about 30 to 80 The prognosis of AKI is mainly related to the cause and severity of complications For AKI caused by pre-renal and post-renal causes if diagnosed early and treated promptly most patients can recover well in renal function For patients with AKI caused by renal parenchymal disease the degree of recovery varies depending on the cause and some patients will have chronic renal damage When the duration of AKI is greater than or equal to three months it can be called CKD More than 700 million people worldwide suffer from kidney disease and CKD is the third leading cause of death after tumors and heart disease CKD can be caused by a variety of kidney diseases such as diabetic nephropathy hypertensive nephropathy and chronic glomerulonephritis In addition there is a special type of renal transplant insufficiency which refers to the renal insufficiency that occurs after a patient undergoes a kidney transplant
In recent years people have gradually paid more and more attention to the relationship between various metabolic diseases and body composition analysis and renal insufficiency These are all risk factors for renal insufficiency Early identification and management of these risk factors is of great significance to the prognosis and delaying disease progression in patients with renal insufficiency Over the past 40 years global obesity rates have continued to rise with more than one-third of countries having their rates doubled Moreover obesity is related to various mechanisms such as insulin resistance and obese patients are also more likely to suffer from various metabolic diseases Therefore obesity is also a factor in renal insufficiency that needs to be prevented and managed urgently There are anatomical cellular and molecular differences in adipose tissue in different parts of the human body Therefore it is of great significance to more accurately measure and divide adipose tissue and muscle in the human body and explore its correlation with renal insufficiency Various metabolic diseases have a high incidence rate long course affect tissues and organs throughout the body and are important risk factors and causes of renal insufficiency Therefore it is also important to explore their correlation with renal insufficiency and explore related mechanisms Contribute to doctors clinical diagnosis and subsequent auxiliary designation of treatment plans
However regardless of its pathogenesis renal fibrosis is the final pathological manifestation of CKD Its main pathological characteristics are inflammatory cell infiltration fibroblast proliferation extracellular matrix ECM deposition and replacement of normal kidney tissue by scar tissue Renal fibrosis is the main determinant of renal insufficiency and its presence and extent are closely related to CKD disease progression and prognosis Early diagnosis and accurate assessment of the degree of renal insufficiency and renal fibrosis are effective means of delaying the development of end-stage renal disease and are of great clinical significance in improving the survival rate and quality of life of patients with renal insufficiency
Usually the indicator used clinically to evaluate renal function is the estimated glomerular filtration rate eGFR as well as urea creatinine uric acid and bicarbonate to assist in the evaluation However these indicators are easily affected by many factors such as drugs and diet are not very accurate and may change significantly in a short period of time More importantly these indicators reflect overall kidney function When patients have mild kidney damage and are in the early stages of kidney disease these indicators are usually still within the normal range By the time they are significantly reduced patients have usually developed irreversible kidney damage The Gates method of renal dynamic imaging is currently the only method widely used in clinical practice to evaluate renal function However its examination time is long more than half an hour the price is high and it also imposes a radiation dose on the patient which limits its routine clinical applicationCurrently renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis but it is invasive and carries the risk of serious complications and the sampled tissue is only a small part of the kidney which is prone to sampling bias The lack of reliable comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs Therefore the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved
With the continuous development and update of technology imaging provides a new way to non-invasively evaluate renal fibrosis Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status physical properties and molecular properties of the kidney For example diffusion weighted imaging DWI can detect the renal fibrosis process Changes in the movement of water molecules caused by deposition of extracellular matrix components infiltration of inflammatory cells and fibroblasts and renal tubular atrophy arterial spin labeling ASL imaging can detect changes in microvascular perfusion blood oxygen level dependence blood oxygen level oxygenation level-dependent BOLD imaging can detect the decrease in tissue oxygenation levels caused by vascular occlusion magnetic resonance elastography MRE can detect the increase in kidney tissue stiffness caused by fibrosis magnetization transfer imaging MT can detect the content of macromolecules such as collagen etc
In recent years in the context of precision medicine artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis It can extract and learn features in images with high throughput make greater use of information in medical images that cannot be recognized by the human eye and achieve disease diagnosis prognosis assessment and efficacy prediction by building models However most of the current research is in the preliminary stage and there are still few studies on the assessment of renal insufficiency and renal fibrosis I believe that with the continuous improvement of algorithms and the optimization of models the progress of radiomics and machine learning will be great To a certain extent it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis
This study aims to explore the value of new imaging technologies in the evaluation of patients with renal insufficiency and renal fibrosis including transplanted renal insufficiency By obtaining clinical imaging laboratory examination and pathological data of patients with renal insufficiency and renal fibrosis we will use Image processing software analyzes images to explore the relationship between image parameters body composition and metabolic diseases and the degree of renal insufficiency and renal fibrosis in patients to achieve non-invasive diagnosis efficacy evaluation and prognosis prediction of renal insufficiency and renal fibrosis etc thereby guiding clinical treatment and improving the survival rate and quality of life of patients with renal insufficiency
Research steps
1 Collection of imaging data Include patients with the above criteria communicate with them and make them informed before signing an informed consent form It is recommended that for MR examinations prescribed by the attending physician patients should fast for 8 hours and water for 4 hours before the examination After the examination the patients imaging data information should be organized and information such as image ID and examination item type should be recorded
2 Image data processing Use the PACS system and GE workstation to copy the image data in DICOM format use image processing software to conduct qualitative and quantitative analysis and record relevant parameter values
3 Clinical data collection Query the list of patients through the Radiation Information System RIS of the Radiology Department of Tongji Hospital and collect clinical data laboratory test data such as serum creatinine glomerular filtration rate eGFR etc and pathological data such as the degree of renal fibrosis conduct case screening based on the exclusion criteria of this study and record the patients medical history in detail including gender age height weight blood pressure past medical history etc and laboratory test data including blood routine blood biochemistry creatinine urea and uric acid bicarbonate glomerular filtration rate eGFR urinary protein urinary protein to creatinine ratio etc pathological data pathological type classification and grading score renal fibrosis degree score etc The treatment situation includes treatment plan medication treatment time etc Disease follow-up information and other information
4 Group patients with renal insufficiency and renal fibrosis through laboratory test data such as serum creatinine glomerular filtration rate eGFR etc pathological data such as renal fibrosis degree or score or treatment efficacy and compare the groups Differences in relevant imaging parameters exploring the ability of different imaging technologies to evaluate renal insufficiency and renal fibrosis aiming to realize the application of imaging in non-invasive diagnosis efficacy evaluation and prognosis prediction of renal insufficiency and renal fibrosis thereby guiding clinical practice decision making
7 Possible risks and preventive measures
Possible risks
This study requires access to patient imaging examination data and electronic medical record data and there may be risks of leakage of patient privacy and other information
Precautions
The imaging data and electronic medical record data used in this study are all data stored by the hospital which can only be viewed by medical workers except the patients themselves and are used to guide the diagnosis and treatment of diseases and are not used for any commercial activities The data recorded and used by this institute including imaging images do not contain any identifier that can identify the patient Therefore the patients personal information can be effectively protected
8 Data collection and statistical analysis The data are mainly image parameters analyzed by image processing software After completing the collection of clinical information laboratory data and prognostic data they are sorted according to the grouping situation and analyzed using statistical software such as SPSS
In recent years people have gradually paid more and more attention to the relationship between various metabolic diseases and body composition analysis and renal insufficiency These are all risk factors for renal insufficiency Early identification and management of these risk factors is of great significance to the prognosis and delaying disease progression in patients with renal insufficiency Over the past 40 years global obesity rates have continued to rise with more than one-third of countries having their rates doubled Moreover obesity is related to various mechanisms such as insulin resistance and obese patients are also more likely to suffer from various metabolic diseases Therefore obesity is also a factor in renal insufficiency that needs to be prevented and managed urgently There are anatomical cellular and molecular differences in adipose tissue in different parts of the human body Therefore it is of great significance to more accurately measure and divide adipose tissue and muscle in the human body and explore its correlation with renal insufficiency Various metabolic diseases have a high incidence rate long course affect tissues and organs throughout the body and are important risk factors and causes of renal insufficiency Therefore it is also important to explore their correlation with renal insufficiency and explore related mechanisms Contribute to doctors clinical diagnosis and subsequent auxiliary designation of treatment plans
However regardless of its pathogenesis renal fibrosis is the final pathological manifestation of CKD Its main pathological characteristics are inflammatory cell infiltration fibroblast proliferation extracellular matrix ECM deposition and replacement of normal kidney tissue by scar tissue Renal fibrosis is the main determinant of renal insufficiency and its presence and extent are closely related to CKD disease progression and prognosis Early diagnosis and accurate assessment of the degree of renal insufficiency and renal fibrosis are effective means of delaying the development of end-stage renal disease and are of great clinical significance in improving the survival rate and quality of life of patients with renal insufficiency
Usually the indicator used clinically to evaluate renal function is the estimated glomerular filtration rate eGFR as well as urea creatinine uric acid and bicarbonate to assist in the evaluation However these indicators are easily affected by many factors such as drugs and diet are not very accurate and may change significantly in a short period of time More importantly these indicators reflect overall kidney function When patients have mild kidney damage and are in the early stages of kidney disease these indicators are usually still within the normal range By the time they are significantly reduced patients have usually developed irreversible kidney damage The Gates method of renal dynamic imaging is currently the only method widely used in clinical practice to evaluate renal function However its examination time is long more than half an hour the price is high and it also imposes a radiation dose on the patient which limits its routine clinical applicationCurrently renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis but it is invasive and carries the risk of serious complications and the sampled tissue is only a small part of the kidney which is prone to sampling bias The lack of reliable comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs Therefore the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved
With the continuous development and update of technology imaging provides a new way to non-invasively evaluate renal fibrosis Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status physical properties and molecular properties of the kidney For example diffusion weighted imaging DWI can detect the renal fibrosis process Changes in the movement of water molecules caused by deposition of extracellular matrix components infiltration of inflammatory cells and fibroblasts and renal tubular atrophy arterial spin labeling ASL imaging can detect changes in microvascular perfusion blood oxygen level dependence blood oxygen level oxygenation level-dependent BOLD imaging can detect the decrease in tissue oxygenation levels caused by vascular occlusion magnetic resonance elastography MRE can detect the increase in kidney tissue stiffness caused by fibrosis magnetization transfer imaging MT can detect the content of macromolecules such as collagen etc
In recent years in the context of precision medicine artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis It can extract and learn features in images with high throughput make greater use of information in medical images that cannot be recognized by the human eye and achieve disease diagnosis prognosis assessment and efficacy prediction by building models However most of the current research is in the preliminary stage and there are still few studies on the assessment of renal insufficiency and renal fibrosis I believe that with the continuous improvement of algorithms and the optimization of models the progress of radiomics and machine learning will be great To a certain extent it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis
This study aims to explore the value of new imaging technologies in the evaluation of patients with renal insufficiency and renal fibrosis including transplanted renal insufficiency By obtaining clinical imaging laboratory examination and pathological data of patients with renal insufficiency and renal fibrosis we will use Image processing software analyzes images to explore the relationship between image parameters body composition and metabolic diseases and the degree of renal insufficiency and renal fibrosis in patients to achieve non-invasive diagnosis efficacy evaluation and prognosis prediction of renal insufficiency and renal fibrosis etc thereby guiding clinical treatment and improving the survival rate and quality of life of patients with renal insufficiency
Research steps
1 Collection of imaging data Include patients with the above criteria communicate with them and make them informed before signing an informed consent form It is recommended that for MR examinations prescribed by the attending physician patients should fast for 8 hours and water for 4 hours before the examination After the examination the patients imaging data information should be organized and information such as image ID and examination item type should be recorded
2 Image data processing Use the PACS system and GE workstation to copy the image data in DICOM format use image processing software to conduct qualitative and quantitative analysis and record relevant parameter values
3 Clinical data collection Query the list of patients through the Radiation Information System RIS of the Radiology Department of Tongji Hospital and collect clinical data laboratory test data such as serum creatinine glomerular filtration rate eGFR etc and pathological data such as the degree of renal fibrosis conduct case screening based on the exclusion criteria of this study and record the patients medical history in detail including gender age height weight blood pressure past medical history etc and laboratory test data including blood routine blood biochemistry creatinine urea and uric acid bicarbonate glomerular filtration rate eGFR urinary protein urinary protein to creatinine ratio etc pathological data pathological type classification and grading score renal fibrosis degree score etc The treatment situation includes treatment plan medication treatment time etc Disease follow-up information and other information
4 Group patients with renal insufficiency and renal fibrosis through laboratory test data such as serum creatinine glomerular filtration rate eGFR etc pathological data such as renal fibrosis degree or score or treatment efficacy and compare the groups Differences in relevant imaging parameters exploring the ability of different imaging technologies to evaluate renal insufficiency and renal fibrosis aiming to realize the application of imaging in non-invasive diagnosis efficacy evaluation and prognosis prediction of renal insufficiency and renal fibrosis thereby guiding clinical practice decision making
7 Possible risks and preventive measures
Possible risks
This study requires access to patient imaging examination data and electronic medical record data and there may be risks of leakage of patient privacy and other information
Precautions
The imaging data and electronic medical record data used in this study are all data stored by the hospital which can only be viewed by medical workers except the patients themselves and are used to guide the diagnosis and treatment of diseases and are not used for any commercial activities The data recorded and used by this institute including imaging images do not contain any identifier that can identify the patient Therefore the patients personal information can be effectively protected
8 Data collection and statistical analysis The data are mainly image parameters analyzed by image processing software After completing the collection of clinical information laboratory data and prognostic data they are sorted according to the grouping situation and analyzed using statistical software such as SPSS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None