NephrectomyNCT07294859
Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy
An observational study of Nephrectomy and Renal Cell Cancer, run by Jinling Hospital, China at 1 site in China.
Trial summary
The goal of this prospective cohort study is to evaluate the predictive value of Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI) technologies regarding renal function outcomes in patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy, Renal Cell Cancer, AKI - Acute Kidney Injury
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2027
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for radical or partial nephrectomy who met all inclusion criteria but did not meet any exclusion criteria
Who may be able to join
- Fully understood and voluntarily signed the informed Consent Form (ICF);
- Age: > 18 (at the time of signing the informed consent form); Gender is not limited.
- Preoperative eGFR > 45ml/min/1.73m2 (corrected CKD-EPI formula);
- After the clinician formulates the treatment plan and communicates with the patient, they decide whether to perform radical nephrectomy or partial nephrectomy.
- ECOG score: 0-2 points;
- Be willing and able to abide by the visits, treatments, laboratory tests and other procedures of the research plan.
Who cannot join
- Patients with solitary kidney or severe contralateral renal insufficiency (eGFR < 15ml/min/1.73m2);
- Preoperative reliance on renal replacement therapy (such as dialysis, etc.);
- Those who fail to complete the nephrectomy as planned during the operation;
- Patients with lymph node metastasis, distant metastasis or venous tumor thrombus;
- The healthy kidney has undergone radiotherapy, ablation or other surgeries.
- Have a history of allergy to ultrasound contrast agents;
Show all 11Show fewer
- Have any contraindications for contrast-enhanced ultrasound, such as right-to-left shunt, severe pulmonary hypertension, etc.
- Patients with hemodynamic instability, including those with persistent hypotension (blood pressure < 90/60 MMHG), uncontrollable heart failure, active bleeding (such as gastrointestinal and cerebral hemorrhage, etc.), or those with a bleeding tendency and hemoglobin < 60g/L and/or platelet count < 50×109/L;
- Accompanied by structural abnormalities of the urinary system or functional abnormalities that cannot be corrected in a short time (such as duplicate kidneys, polycystic kidneys, horseshoe kidneys, isolated kidneys, renal artery stenosis > 50%, urinary tract obstruction, and previous history of kidney surgery, etc.), long-term indwelling of urinary catheters, etc.
- There are other diseases that limit life expectancy to less than six months;
- Previous (≤30 days before randomization) or concurrent participation in another clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210000
Le Qu, +86 15720625951, septsoul@hotmail.com
About this study
Official title: A Prospective Clinical Study on the Predictive Value of CEUS and Super-resolution Imaging Technology for Renal Function Outcome in Patients After Partial or Radical Nephrectomy
The goal of this prospective cohort study is to evaluate the predictive value of Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI) technologies regarding renal function outcomes in patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy. The main questions it aims to answer are:
Can quantitative parameters of renal microcirculation and microvascular structure derived from CEUS and SRI predict long-term renal function (defined as New Baseline eGFR for radical nephrectomy and Recovery from Ischemia for partial nephrectomy)? Can these imaging parameters accurately predict the occurrence, severity, and early recovery of postoperative acute kidney injury (AKI)? Researchers will monitor the dynamic evolution of renal blood flow and microvascular density by comparing the affected kidney to the contralateral healthy kidney before and after surgery to see if these biomarkers correlate with clinical outcomes.
Read more
Participants will:
Undergo CEUS and SRI examinations before surgery and at specific time points after surgery (e.g., within 7 days) to visualize renal microvasculature.
Provide blood and urine samples for standard laboratory tests (such as serum creatinine and Cystatin C) to assess kidney function during hospitalization.
Attend follow-up visits at 1, 3, 6, 9, and 12 months post-surgery to monitor long-term renal recovery and complete necessary imaging assessments (CT or Ultrasound).
Read the detailed description
This study is a prospective cohort study aimed at evaluating the predictive value of contrast-enhanced ultrasound and super-resolution imaging techniques for renal function outcomes in patients after nephrectomy. The study intends to include approximately 285 patients with renal cell carcinoma who are scheduled to undergo partial nephrectomy or radical nephrectomy. The core of this study is to non-invasive and quantitatively monitor the microcirculation perfusion (such as hemodynamic parameters) and microvascular structure (such as microvascular density and glomerular density) of the affected and healthy kidneys at multiple time points before and after the operation by applying contrast-enhanced ultrasound and super-resolution imaging techniques, and simultaneously collect clinical data.
The main contents of this study include: longitudinal observation of the dynamic evolution patterns of renal microcirculation parameters before and after the operation; Analyze the correlations between these imaging parameters and the occurrence, severity and prognosis of postoperative acute kidney injury, and simultaneously explore the association between the occurrence and development of early AKI and long-term renal function changes; Ultimately, the goal is to combine predictive imaging parameters with traditional clinical variables (such as age, preoperative renal function, etc.) to construct integrated mathematical models for different surgical methods (partial nephrectomy and radical nephrectomy), in order to accurately predict the early (postoperative acute kidney injury) and long-term renal function (such as new baseline estimated glomerular filtration rate) of patients. Meanwhile, considering the compensatory function of contralateral renal function after PN, Rec-Ischemia was adopted as the primary endpoint indicator to evaluate the changes of ipsilateral postoperative renal function in patients after PN. This study is expected to provide innovative imaging biomarkers and decision support for individualized management and early intervention of renal function after nephrectomy.
- Conditions
- Nephrectomy, Renal Cell Cancer, AKI - Acute Kidney Injury
- Medical subject headings
- Carcinoma, Renal Cell, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for radical nephrectomy | Not described | |
| Patients scheduled for partial nephrectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
new baseline estimates glomerular filtration rate(NB-eGFR)
NB-eGFR is defined as multiple eGFR tests conducted within 3 to 12 months after surgery, and the last eGFR measurement value within this time window (the calculation of eGFR uses the corrected CKD-EPI formula)
Measured: 12 months after nephrectomy
Rec-Ischemia
This outcome is mainly applicable to patients undergoing partial nephrectomy. It is defined as the ratio of the ipsilateral GFR retention rate to the renal parenchymal retention rate (PPVP), that is, the degree of functional recovery of the retained renal parenchyma per unit. The calculation formula is Rec-Ischemia= ipsilateral GFR retention rate /PPVP×100%13.
Ipsilateral GFR retention rate = postoperative ipsilateral GFR/ preoperative ipsilateral GFR×100%, PPVP= postoperative ipsilateral renal parenchymal volume/preoperative ipsilateral renal parenchymal volume ×100%. The predicted ipsilateral GFR after surgery = the total postoperative GFR× the expected retained SRF of the affected kidney. The expected retained SRF of the affected kidney = the parenchymal volume of the affected kidney/(the parenchymal volume of the affected kidney + the parenchymal volume of the contralateral kidney).
Measured: 12 months after partial nephrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Sep 2025
- Primary completion1 Nov 2027 (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 NephrectomyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294859
- Sponsor's protocol ID
- DZQH-KYLL-25-37
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study on the Predictive Value of CEUS and Super-resolution Imaging Technology for Renal Function Outcome in Patients After Partial or Radical Nephrectomy
- ClinicalTrials.gov ID
- NCT07294859
- Acronym / sponsor ID
- DZQH-KYLL-25-37
- Conditions
- Nephrectomy, Renal Cell Cancer, AKI - Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Dec 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.
The goal of this prospective cohort study is to evaluate the predictive value of Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI) technologies regarding renal function outcomes in patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy. The main questions it aims to answer are:
Can quantitative parameters of renal microcirculation and microvascular structure derived from CEUS and SRI predict long-term renal function (defined as New Baseline eGFR for radical nephrectomy and Recovery from Ischemia for partial nephrectomy)? Can these imaging parameters accurately predict the occurrence, severity, and early recovery of postoperative acute kidney injury (AKI)? Researchers will monitor the dynamic evolution of renal blood flow and microvascular density by comparing the affected kidney to the contralateral healthy kidney before and after surgery to see if these biomarkers correlate with clinical outcomes.
Participants will:
Undergo CEUS and SRI examinations before surgery and at specific time points after surgery (e.g., within 7 days) to visualize renal microvasculature.
Provide blood and urine samples for standard laboratory tests (such as serum creatinine and Cystatin C) to assess kidney function during hospitalization.
Attend follow-up visits at 1, 3, 6, 9, and 12 months post-surgery to monitor long-term renal recovery and complete necessary imaging assessments (CT or Ultrasound).
Detailed description
This study is a prospective cohort study aimed at evaluating the predictive value of contrast-enhanced ultrasound and super-resolution imaging techniques for renal function outcomes in patients after nephrectomy. The study intends to include approximately 285 patients with renal cell carcinoma who are scheduled to undergo partial nephrectomy or radical nephrectomy. The core of this study is to non-invasive and quantitatively monitor the microcirculation perfusion (such as hemodynamic parameters) and microvascular structure (such as microvascular density and glomerular density) of the affected and healthy kidneys at multiple time points before and after the operation by applying contrast-enhanced ultrasound and super-resolution imaging techniques, and simultaneously collect clinical data.
The main contents of this study include: longitudinal observation of the dynamic evolution patterns of renal microcirculation parameters before and after the operation; Analyze the correlations between these imaging parameters and the occurrence, severity and prognosis of postoperative acute kidney injury, and simultaneously explore the association between the occurrence and development of early AKI and long-term renal function changes; Ultimately, the goal is to combine predictive imaging parameters with traditional clinical variables (such as age, preoperative renal function, etc.) to construct integrated mathematical models for different surgical methods (partial nephrectomy and radical nephrectomy), in order to accurately predict the early (postoperative acute kidney injury) and long-term renal function (such as new baseline estimated glomerular filtration rate) of patients. Meanwhile, considering the compensatory function of contralateral renal function after PN, Rec-Ischemia was adopted as the primary endpoint indicator to evaluate the changes of ipsilateral postoperative renal function in patients after PN. This study is expected to provide innovative imaging biomarkers and decision support for individualized management and early intervention of renal function after nephrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for radical nephrectomy | – | – |
| Patients scheduled for partial nephrectomy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for radical or partial nephrectomy who met all inclusion criteria but did not meet any exclusion criteria
Key inclusion criteria (6 listed)
- Fully understood and voluntarily signed the informed Consent Form (ICF);
- Age: > 18 (at the time of signing the informed consent form); Gender is not limited.
- Preoperative eGFR > 45ml/min/1.73m2 (corrected CKD-EPI formula);
- After the clinician formulates the treatment plan and communicates with the patient, they decide whether to perform radical nephrectomy or partial nephrectomy.
- ECOG score: 0-2 points;
Key exclusion criteria (11 listed)
- Patients with solitary kidney or severe contralateral renal insufficiency (eGFR < 15ml/min/1.73m2);
- Preoperative reliance on renal replacement therapy (such as dialysis, etc.);
- Those who fail to complete the nephrectomy as planned during the operation;
- Patients with lymph node metastasis, distant metastasis or venous tumor thrombus;
- The healthy kidney has undergone radiotherapy, ablation or other surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
new baseline estimates glomerular filtration rate(NB-eGFR)
Time frame: 12 months after nephrectomy
NB-eGFR is defined as multiple eGFR tests conducted within 3 to 12 months after surgery, and the last eGFR measurement value within this time window (the calculation of eGFR uses the corrected CKD-EPI formula)
Rec-Ischemia
Time frame: 12 months after partial nephrectomy
This outcome is mainly applicable to patients undergoing partial nephrectomy. It is defined as the ratio of the ipsilateral GFR retention rate to the renal parenchymal retention rate (PPVP), that is, the degree of functional recovery of the retained renal parenchyma per unit. The calculation formula is Rec-Ischemia= ipsilateral GFR retention rate /PPVP×100%13. Ipsilateral GFR retention rate = postoperative ipsilateral GFR/ preoperative ipsilateral GFR×100%, PPVP= postoperative ipsilateral renal parenchymal volume/preoperative ipsilateral renal parenchymal volume ×100%. The predicted ipsilateral GFR after surgery = the total postoperative GFR× the expected retained SRF of the affected kidney. The expected retained SRF of the affected kidney = the parenchymal volume of the affected kidney/(the parenchymal volume of the affected kidney + the parenchymal volume of the contralateral kidney).
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 19 Dec 2025.
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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.
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 Nephrectomy and Renal Cell Cancer, run by Jinling Hospital, China at 1 site in China.
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 6 inclusion and 11 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 19 Dec 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 China. 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 Le Qu (+86 15720625951, septsoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new baseline estimates glomerular filtration rate(NB-eGFR) (time frame: 12 months after nephrectomy). The study lists 2 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 19 Dec 2025.