Congenital Anomalies of Kidney and Urinary TractSearch_CAKUTNCT06921733
Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
An observational study of Congenital Anomalies of Kidney and Urinary Tract and Lower Urinary Tract Obstruction, Congenital, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This clinical study aims to non-invasively visualize perfusion and microvascularization, as well as individual glomeruli, using Ultrasound Localization Microscopy (ULM) and CEUS in patients with congenital anomalies of the kidney and urinary tract (CAKUT). Read more about this study
- Who is it for?
- Ages 0 months to 6 years
- Conditions the study is for
- Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital, Ureteropelvic Junction Obstruction
- What is being tested?
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: One study population. Anticipated approx. n=20 children with above mentioned inclusion criteria with congenital anomalies of the kidney and urinary tract and inclusion criteria for MAG3 scintigraphy
Who may be able to join
- Minimum Age 1 Month Maximum Age 6 Years Indication for MAG3 Scintigraphy of the Kidney Congenital Anomalies of the Kidney and Urinary Tract Obstruction Diagnosis Availability of the qualified examiner Consent of the parents/legal guardians
Who cannot join
- Lack of consent of at least one parent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Regensburger Regensburger, PD Dr. med. Dr. rer. biol. Hum contact
Dr. med. Alina Hilger contact
Germany1 site, 1 recruiting
- Recruiting
FAU Erlangen-Nuernberg,
Erlangen, Bavaria, 91054
PD Dr. med. Dr. rer. biol. Hum. Adrian Regensburger, adrian.regensburger@uk-erlangen.de
Dr. med. Alina Hilger, alina.hilger@uk-erlangen.de
About this study
Official title: Non-invasive Evaluation of Kidneys in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Using Ultrasound Localization Microscopy
This clinical study aims to non-invasively visualize perfusion and microvascularization, as well as individual glomeruli, using Ultrasound Localization Microscopy (ULM) and CEUS in patients with congenital anomalies of the kidney and urinary tract (CAKUT).
Read the detailed description
Congenital anomalies of the kidney and urinary tract (CAKUT) affect 0.5% of newborns and account for 20% of all congenital malformations. These conditions are associated with chronic kidney failure, a need for dialysis, and significantly increased mortality (30 times higher than healthy peers) and morbidity. Patients with CAKUT face substantial health and socioeconomic burdens due to lifelong therapy requirements. In Europe, CAKUT is the leading cause of dialysis-dependent chronic kidney failure.
All CAKUT disorders arise in utero, interfering with kidney development and leading to reduced nephron formation. Many congenital kidney anomalies are diagnosed via prenatal ultrasound. These anomalies include ureteropelvic junction obstruction, often presenting as unilateral hydronephrosis, and posterior urethral valves, which can be associated with megacystis and bilateral hydronephrosis. The resulting urinary obstruction can cause pressure damage to kidney tissue during fetal development, further reducing functional nephron mass. Postnatally, ongoing pressure damage can lead to renal remodeling. The decreased nephron mass and remodeling increase the long-term risk of kidney insufficiency, which is currently assessed only by serum creatinine levels-these are delayed and less sensitive in infants and young children. Reliable biomarkers for reduced nephron mass or renal remodeling to predict chronic kidney injury risk in CAKUT patients are currently lacking. Currently, the actual pressure impact of sonographically detectable urinary obstruction can only be assessed through urine flow patterns using MAG-3 scintigraphy. However, this method is dependent on kidney function, which can affect the uptake and excretion of the radiopharmaceutical and subsequently influence the evaluation of results.
The intravenous use of ultrasound contrast enhancers as an aid opens up the possibility of recording the tissue perfusion of the kidneys, including the smallest vessels, independent of the kidney function. This could provide significantly more information compared to conventional methods and expand our knowledge of the pathophysiology and individual status of tissue perfusion in patients.
In this clinical study, the new CEUS measurement and imaging technique will be used after the kidney scintigraphy. A contrast agent (SonoVue®) will be administered during the routine ultrasound examination and improved tissue visualization will be achieved. The aim is to gain new insights into kidney perfusion as part of the treatment and to better assess the extent of organ damage in the individual patient through more specific vascular imaging. Finally, the aim is to compare diagnostic and prognostic methods with the currently recommended measures. The CEUS is to be examined as a possible diagnostic imaging tool and possibly a supplement to existing diagnostic methods.
- Conditions
- Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital, Ureteropelvic Junction Obstruction, Hydronephrosis Congenital
- Being tested
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Medical subject headings
- Cakut, Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMDevice
CEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics.
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital anomalies of the kidney and urinary tract (CAKUT) with indication for MAG3 | Included will be children under the age of 6 with congenital anomalies of the kidney and urinary tract (CAKUT)that get an indication for a MAG3 scintigraphy. They will be monitored with CEUS/ULM after the MAG3 scintigraphy. Receives: Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEUS Measurement1
PE (Peak-Enhancement)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Time intensity curves
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement2
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement4
RT (Rise Time)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement5
mTT (mean Transit Time local) (mTT-TI))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement6
TTP (Time to Peak)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement7
WiR (Wash-in-Rate )
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement8
WiPI (Wash-in Perfusion Index (WiAUC/RT))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement9
WoAUC (Wash-out AUC (AUC(TTP:TO)))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement10
WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement11
FT (Fall Time - (TO-TTP))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement12
WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement13
QOF (Quality Of Fit between the echo-power signal and f(t)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Visualization and quantification of kidney perfusion with CEUS
CEUS imaging for kidney perfusion in CAKUT
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Visualization and quantification of kidney mikrovaskularisation with ULM
ULM imaging for kidney perfusion and mikrovaskularisation in CAKUT
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Visualization and quantification of glomeruli in the kidney with ULM
ULM imaging for glomeruli in the kidney
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Secondary outcomes (15)
ULM and Ultrasound
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with sonographic parameters (including Resistance Index (RI), flow velocity).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and CEUS
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with parameters of contrast-enhanced ultrasound (CEUS).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and Biopsy
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (including the number of segmented glomeruli) with histological parameters.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on affected and unaffected kidney
Comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) between the affected and unaffected kidney in the same patient.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and Scintigraphy
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with parameters from renal scintigraphy (e.g., perfusion parameters).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Pressure changes with CEUS
Visualization of pressure changes in the kidney using the vascular architecture visualized by CEUS and parameters of quantified microvascular perfusion dynamics.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Pressure changes with ULM
Visualization of pressure changes in the kidney using the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Comparison of the kidney before and after intervention with ULM
Comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) before and after intervention
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on different diagnoses
Comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) between different diagnoses.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on clinical outcomes
Correlation and comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with clinical criteria and clinical outcomes (surgical success).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Correlation between ULM and laboratory parameters
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with laboratory parameters (including kidney function parameters, inflammatory markers, and immunological parameters).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function GFR
GFR (ml/min/1,73 m2)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function urea
urea (mg/dl)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function urinary status
standardized urinary status
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assesment of renal function kreatininekinase
kreatininekinase (U/l)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start13 May 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Anomalies of Kidney and Urinary TractStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921733
- Sponsor's protocol ID
- Search_CAKUT_ULM
- Acronym
- Search_CAKUT
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Kidneys in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Using Ultrasound Localization Microscopy
- ClinicalTrials.gov ID
- NCT06921733
- Acronym / sponsor ID
- Search_CAKUT / Search_CAKUT_ULM
- Conditions
- Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital, Ureteropelvic Junction Obstruction, Hydronephrosis Congenital
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
This clinical study aims to non-invasively visualize perfusion and microvascularization, as well as individual glomeruli, using Ultrasound Localization Microscopy (ULM) and CEUS in patients with congenital anomalies of the kidney and urinary tract (CAKUT).
Detailed description
Congenital anomalies of the kidney and urinary tract (CAKUT) affect 0.5% of newborns and account for 20% of all congenital malformations. These conditions are associated with chronic kidney failure, a need for dialysis, and significantly increased mortality (30 times higher than healthy peers) and morbidity. Patients with CAKUT face substantial health and socioeconomic burdens due to lifelong therapy requirements. In Europe, CAKUT is the leading cause of dialysis-dependent chronic kidney failure.
All CAKUT disorders arise in utero, interfering with kidney development and leading to reduced nephron formation. Many congenital kidney anomalies are diagnosed via prenatal ultrasound. These anomalies include ureteropelvic junction obstruction, often presenting as unilateral hydronephrosis, and posterior urethral valves, which can be associated with megacystis and bilateral hydronephrosis. The resulting urinary obstruction can cause pressure damage to kidney tissue during fetal development, further reducing functional nephron mass. Postnatally, ongoing pressure damage can lead to renal remodeling. The decreased nephron mass and remodeling increase the long-term risk of kidney insufficiency, which is currently assessed only by serum creatinine levels-these are delayed and less sensitive in infants and young children. Reliable biomarkers for reduced nephron mass or renal remodeling to predict chronic kidney injury risk in CAKUT patients are currently lacking. Currently, the actual pressure impact of sonographically detectable urinary obstruction can only be assessed through urine flow patterns using MAG-3 scintigraphy. However, this method is dependent on kidney function, which can affect the uptake and excretion of the radiopharmaceutical and subsequently influence the evaluation of results.
The intravenous use of ultrasound contrast enhancers as an aid opens up the possibility of recording the tissue perfusion of the kidneys, including the smallest vessels, independent of the kidney function. This could provide significantly more information compared to conventional methods and expand our knowledge of the pathophysiology and individual status of tissue perfusion in patients.
In this clinical study, the new CEUS measurement and imaging technique will be used after the kidney scintigraphy. A contrast agent (SonoVue®) will be administered during the routine ultrasound examination and improved tissue visualization will be achieved. The aim is to gain new insights into kidney perfusion as part of the treatment and to better assess the extent of organ damage in the individual patient through more specific vascular imaging. Finally, the aim is to compare diagnostic and prognostic methods with the currently recommended measures. The CEUS is to be examined as a possible diagnostic imaging tool and possibly a supplement to existing diagnostic methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with congenital anomalies of the kidney and urinary tract (CAKUT) with indication for MAG3 | – | Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMIncluded will be children under the age of 6 with congenital anomalies of the kidney and urinary tract (CAKUT)that get an indication for a MAG3 scintigraphy. They will be monitored with CEUS/ULM after the MAG3 scintigraphy. |
Who may qualify
- Ages
- 0 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- One study population. Anticipated approx. n=20 children with above mentioned inclusion criteria with congenital anomalies of the kidney and urinary tract and inclusion criteria for MAG3 scintigraphy
Key inclusion criteria (1 listed)
- Minimum Age 1 Month Maximum Age 6 Years Indication for MAG3 Scintigraphy of the Kidney Congenital Anomalies of the Kidney and Urinary Tract Obstruction Diagnosis Availability of the qualified examiner Consent of the parents/legal guardians
Key exclusion criteria (1 listed)
- Lack of consent of at least one parent
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 |
|---|---|---|
| Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMCEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics. | Device | Children with congenital anomalies of the kidney and urinary tract (CAKUT) with indication for MAG3 |
Primary outcome
CEUS Measurement1
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
PE (Peak-Enhancement)
CEUS Time intensity curves
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
CEUS Measurement2
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
CEUS Measurement4
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
RT (Rise Time)
CEUS Measurement5
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
mTT (mean Transit Time local) (mTT-TI))
CEUS Measurement6
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
TTP (Time to Peak)
CEUS Measurement7
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
WiR (Wash-in-Rate )
CEUS Measurement8
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
WiPI (Wash-in Perfusion Index (WiAUC/RT))
CEUS Measurement9
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
WoAUC (Wash-out AUC (AUC(TTP:TO)))
CEUS Measurement10
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))
CEUS Measurement11
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
FT (Fall Time - (TO-TTP))
CEUS Measurement12
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)
CEUS Measurement13
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
QOF (Quality Of Fit between the echo-power signal and f(t)
Visualization and quantification of kidney perfusion with CEUS
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS imaging for kidney perfusion in CAKUT
Visualization and quantification of kidney mikrovaskularisation with ULM
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM imaging for kidney perfusion and mikrovaskularisation in CAKUT
Visualization and quantification of glomeruli in the kidney with ULM
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM imaging for glomeruli in the kidney
15 secondary outcomes
ULM and Ultrasound
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and CEUS
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and Biopsy
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on affected and unaffected kidney
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and Scintigraphy
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Pressure changes with CEUS
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Pressure changes with ULM
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Comparison of the kidney before and after intervention with ULM
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on different diagnoses
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on clinical outcomes
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Correlation between ULM and laboratory parameters
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function GFR
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function urea
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function urinary status
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Assesment of renal function kreatininekinase
Time frame: Baseline and follow up (1-31 days after routine surgery if indicated)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Regensburger Regensburger, PD Dr. med. Dr. rer. biol. Hum contact
Dr. med. Alina Hilger contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Anomalies of Kidney and Urinary Tract and Lower Urinary Tract Obstruction, Congenital, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regensburger Regensburger, PD Dr. med. Dr. rer. biol. Hum (091318541732, adrian.regensburger@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEUS Measurement1 (time frame: Baseline and follow up (1-31 days after routine surgery if indicated)). The study lists 16 primary outcomes in all. 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 17 Sep 2025.