Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472947
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-18
Brief Title:
Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ESTIMATOR
Brief Summary:
In this study the condition of the kidney transplant in adults is to be assessed non-invasively using Multispectral Optoacoustic Tomography and Ultrasound Localization Microscopy New non-invasive markers that allow conclusions to be drawn about the condition of the transplant should reduce the need for invasive diagnostic procedures in the future
Detailed Description:
In this study the condition of the kidney transplant in adults is to be assessed non-invasively using multispectral multispectral optoacoustic tomography and ultrasound localization microscopy Associated with common diseases such as arterial hypertension diabetes mellitus and cardiovascular diseases chronic renal failure is now a leading cause of death worldwide
Around 10 of adults in Germany but children are also affected The terminal stage of renal insufficiency is defined by a glomerular filtration rate GFR which is only 15 of the normal rate and the need for renal replacement therapy in the form of dialysis or transplantation
Not only the higher quality of life but also the mortality rate make kidney transplantation the procedure of choice whenever possible
After successful kidney transplantation regular monitoring and evaluation of the organ transplant is of great importance to detect a rejection reaction as early as possible
Among other things this is done during an extensive annual examination Not infrequently and especially in the case of abnormalities in the laboratory diagnosis of blood and urine a kidney biopsy is also necessary in order to assess the condition of the transplant in the best possible way
As an invasive diagnostic procedure the biopsy necessitates a stay in hospital may result in side effects such as postoperative bleeding and represents a risk and an additional bruden for the patient
MSOT has already been used to measure renal clearance and the biodistribution of fluorescent substances within the kidney but new biomarkers have also been established in muscle and intestinal diseases and correlated with clinical scores ULM has made the visualization of glomeruli the smallest functional unit of the kidney in living rats and humans and visualization of cerebral microvasculature in the human brain possible In this study the renal function in transplant patients will be evaluated as part of the annual examination and results from histology biopsy laboratory and ultrasound diagnostics will be correlated with data from MSOT and ULM imaging
The investigators believe that MSOT can be used to gain important molecular insights into the condition of the transplant With ULM the investigators want to analyze the microvascular architecture within glomerular renal corpuscles and identify changes in perfusion dynamics as morphological signs for transplant evaluation
Around 10 of adults in Germany but children are also affected The terminal stage of renal insufficiency is defined by a glomerular filtration rate GFR which is only 15 of the normal rate and the need for renal replacement therapy in the form of dialysis or transplantation
Not only the higher quality of life but also the mortality rate make kidney transplantation the procedure of choice whenever possible
After successful kidney transplantation regular monitoring and evaluation of the organ transplant is of great importance to detect a rejection reaction as early as possible
Among other things this is done during an extensive annual examination Not infrequently and especially in the case of abnormalities in the laboratory diagnosis of blood and urine a kidney biopsy is also necessary in order to assess the condition of the transplant in the best possible way
As an invasive diagnostic procedure the biopsy necessitates a stay in hospital may result in side effects such as postoperative bleeding and represents a risk and an additional bruden for the patient
MSOT has already been used to measure renal clearance and the biodistribution of fluorescent substances within the kidney but new biomarkers have also been established in muscle and intestinal diseases and correlated with clinical scores ULM has made the visualization of glomeruli the smallest functional unit of the kidney in living rats and humans and visualization of cerebral microvasculature in the human brain possible In this study the renal function in transplant patients will be evaluated as part of the annual examination and results from histology biopsy laboratory and ultrasound diagnostics will be correlated with data from MSOT and ULM imaging
The investigators believe that MSOT can be used to gain important molecular insights into the condition of the transplant With ULM the investigators want to analyze the microvascular architecture within glomerular renal corpuscles and identify changes in perfusion dynamics as morphological signs for transplant evaluation
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