Renal Cell Carcinoma (RCC)NCT07875959
18F-N230A PET/CT Imaging of Nectin-4 Expression in Renal Tumors
A study testing 18F-N230A in people with Renal Cell Carcinoma (RCC) and Renal Pelvic Urothelial Carcinoma, run by Peking University First Hospital at 1 site in China.
Trial summary
Renal cell carcinoma and renal pelvic urothelial carcinoma are common malignant tumors of the urinary system. Accurate preoperative differentiation between these tumor types is important for treatment planning, while conventional imaging methods may have limitations in characterizing tumor biology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC), Renal Pelvic Urothelial Carcinoma
- What is being tested?
- 18F-N230A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Participants aged ≥18 years.
- Patients with suspected or confirmed renal tumors who are scheduled for pathological examination by biopsy or surgical resection within 2 months.
- Patients who can understand the study procedures and voluntarily provide written informed consent.
- Patients who can cooperate with PET/CT imaging procedures.
Who cannot join
- Patients with severe abnormalities in liver function, renal function, or blood cell counts.
- Patients unable to understand the study procedures or unable to cooperate with imaging examinations.
- Patients with a history of other malignant tumors.
- Patients considered unsuitable for participation by the investigator.
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
Peking University First Hospital
Beijing, Beijing Municipality, 100034
XUEQI CHEN, 86-10-83575252, chenxueqi1989@163.com
About this study
Official title: A Study to Evaluate 18F-N230A PET/CT Imaging of Nectin-4 Expression in Patients With Renal Cell Carcinoma and Renal Pelvic Urothelial Carcinoma
Renal cell carcinoma and renal pelvic urothelial carcinoma are common malignant tumors of the urinary system. Accurate preoperative differentiation between these tumor types is important for treatment planning, while conventional imaging methods may have limitations in characterizing tumor biology.
Nectin-4 is a tumor-associated molecular target that is highly expressed in several epithelial malignancies, particularly urothelial carcinoma. 18F-N230A is a novel PET imaging probe targeting Nectin-4. This study aims to evaluate the safety, biodistribution, and imaging characteristics of 18F-N230A PET/CT in patients with suspected or confirmed renal tumors.
Read more
Participants enrolled in this study will undergo 18F-N230A PET/CT imaging and 18F-FDG PET/CT imaging. The imaging findings and quantitative parameters will be analyzed and compared. Pathological results obtained from surgery or biopsy will be used as the reference standard to evaluate the potential value of 18F-N230A PET/CT in differentiating renal cell carcinoma from renal pelvic urothelial carcinoma.
This study may provide a new molecular imaging approach for improving the preoperative diagnosis of renal tumors and supporting individualized clinical decision-making.
- Being tested
- 18F-N230A
- Keywords
- Renal Cell Carcinoma, Renal Pelvic Urothelial Carcinoma, Nectin-4, 18F-N230A, PET/CT
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-N230ADrug
18F-N230A is a Nectin-4-targeting PET radiopharmaceutical. Participants will receive intravenous administration of 18F-N230A followed by PET/CT imaging to evaluate Nectin-4 expression in renal tumors.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 18F-N230A PET/CT Imaging | Experimental | Participants with suspected or confirmed renal tumors will receive an intravenous injection of 18F-N230A followed by PET/CT imaging. Participants will also undergo 18F-FDG PET/CT imaging for comparison. PET/CT imaging findings will be analyzed and compared with pathological results obtained from surgery or biopsy to evaluate the diagnostic value of 18F-N230A PET/CT for differentiating renal cell carcinoma and renal pelvic urothelial carcinoma. Receives: Drug: 18F-N230A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of 18F-N230A PET/CT
Diagnostic accuracy will be calculated as the percentage of patients correctly classified as having renal cell carcinoma or renal pelvic urothelial carcinoma by 18F-N230A PET/CT, using histopathological findings from surgery or biopsy as the reference standard. Diagnostic accuracy will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
Measured: Up to 2 months after PET/CT imaging
Secondary outcomes (7)
Sensitivity of 18F-N230A PET/CT for Detecting Renal Pelvic Urothelial Carcinoma
Sensitivity will be calculated as the percentage of patients with histopathologically confirmed renal pelvic urothelial carcinoma correctly identified by 18F-N230A PET/CT. Histopathological findings from surgery or biopsy will serve as the reference standard. Sensitivity will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
Measured: Up to 2 months after PET/CT imaging
Specificity of 18F-N230A PET/CT for Detecting Renal Pelvic Urothelial Carcinoma
Specificity will be calculated as the percentage of patients with histopathologically confirmed renal cell carcinoma correctly classified as negative for renal pelvic urothelial carcinoma by 18F-N230A PET/CT. Histopathological findings from surgery or biopsy will serve as the reference standard. Specificity will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
Measured: Up to 2 months after PET/CT imaging
Maximum Standardized Uptake Value (SUVmax) of Renal Lesions
The maximum standardized uptake value (SUVmax) will be measured within renal tumor lesions on 18F-N230A PET/CT and 18F-FDG PET/CT images. SUVmax represents the highest standardized radiotracer uptake within the tumor lesion. Values will be reported separately for each imaging modality as unitless standardized uptake values.
Measured: At the time of PET/CT imaging
Mean Standardized Uptake Value (SUVmean) of Renal Lesions
The mean standardized uptake value (SUVmean) will be measured within renal tumor lesions on 18F-N230A PET/CT and 18F-FDG PET/CT images. SUVmean represents the average standardized radiotracer uptake within the tumor lesion. Values will be reported separately for each imaging modality as unitless standardized uptake values.
Measured: At the time of PET/CT imaging
Lesion-to-Liver Background Uptake Ratio on PET/CT
The lesion-to-liver background uptake ratio will be calculated by dividing the maximum standardized uptake value (SUVmax) of the renal tumor lesion by the mean standardized uptake value (SUVmean) measured in a reference region of normal liver tissue. The ratio will be calculated separately for 18F-N230A PET/CT and 18F-FDG PET/CT. Results will be reported as unitless ratios.
Measured: At the time of PET/CT imaging
Lesion-to-Mediastinal Blood Pool Uptake Ratio on PET/CT
The lesion-to-mediastinal blood pool uptake ratio will be calculated by dividing the maximum standardized uptake value (SUVmax) of the renal tumor lesion by the mean standardized uptake value (SUVmean) measured in the mediastinal blood pool reference region. The ratio will be calculated separately for 18F-N230A PET/CT and 18F-FDG PET/CT. Results will be reported as unitless ratios.
Measured: At the time of PET/CT imaging
Lesion-to-Muscle Uptake Ratio on PET/CT
The lesion-to-muscle uptake ratio will be calculated by dividing the maximum standardized uptake value (SUVmax) of the renal tumor lesion by the mean standardized uptake value (SUVmean) measured in a reference muscle region. The ratio will be calculated separately for 18F-N230A PET/CT and 18F-FDG PET/CT. Results will be reported as unitless ratios.
Measured: At the time of PET/CT imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start9 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua ZHANG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875959
- Sponsor's protocol ID
- [18F]N230A
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate 18F-N230A PET/CT Imaging of Nectin-4 Expression in Patients With Renal Cell Carcinoma and Renal Pelvic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07875959
- Acronym / sponsor ID
- [18F]N230A
- Keywords
- Renal Cell Carcinoma, Renal Pelvic Urothelial Carcinoma, Nectin-4, 18F-N230A, PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Oct 2026 (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.
Renal cell carcinoma and renal pelvic urothelial carcinoma are common malignant tumors of the urinary system. Accurate preoperative differentiation between these tumor types is important for treatment planning, while conventional imaging methods may have limitations in characterizing tumor biology.
Nectin-4 is a tumor-associated molecular target that is highly expressed in several epithelial malignancies, particularly urothelial carcinoma. 18F-N230A is a novel PET imaging probe targeting Nectin-4. This study aims to evaluate the safety, biodistribution, and imaging characteristics of 18F-N230A PET/CT in patients with suspected or confirmed renal tumors.
Participants enrolled in this study will undergo 18F-N230A PET/CT imaging and 18F-FDG PET/CT imaging. The imaging findings and quantitative parameters will be analyzed and compared. Pathological results obtained from surgery or biopsy will be used as the reference standard to evaluate the potential value of 18F-N230A PET/CT in differentiating renal cell carcinoma from renal pelvic urothelial carcinoma.
This study may provide a new molecular imaging approach for improving the preoperative diagnosis of renal tumors and supporting individualized clinical decision-making.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: 18F-N230A PET/CT Imaging | Experimental | Drug: 18F-N230AParticipants with suspected or confirmed renal tumors will receive an intravenous injection of 18F-N230A followed by PET/CT imaging. Participants will also undergo 18F-FDG PET/CT imaging for comparison. PET/CT imaging findings will be analyzed and compared with pathological results obtained from surgery or biopsy to evaluate the diagnostic value of 18F-N230A PET/CT for differentiating renal cell carcinoma and renal pelvic urothelial carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged ≥18 years.
- Patients with suspected or confirmed renal tumors who are scheduled for pathological examination by biopsy or surgical resection within 2 months.
- Patients who can understand the study procedures and voluntarily provide written informed consent.
- Patients who can cooperate with PET/CT imaging procedures.
Key exclusion criteria (4 listed)
- Patients with severe abnormalities in liver function, renal function, or blood cell counts.
- Patients unable to understand the study procedures or unable to cooperate with imaging examinations.
- Patients with a history of other malignant tumors.
- Patients considered unsuitable for participation by the investigator.
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 |
|---|---|---|
| 18F-N230A18F-N230A is a Nectin-4-targeting PET radiopharmaceutical. Participants will receive intravenous administration of 18F-N230A followed by PET/CT imaging to evaluate Nectin-4 expression in renal tumors. | Drug | Experimental: 18F-N230A PET/CT Imaging |
Primary outcome
Diagnostic Accuracy of 18F-N230A PET/CT
Time frame: Up to 2 months after PET/CT imaging
Diagnostic accuracy will be calculated as the percentage of patients correctly classified as having renal cell carcinoma or renal pelvic urothelial carcinoma by 18F-N230A PET/CT, using histopathological findings from surgery or biopsy as the reference standard. Diagnostic accuracy will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
7 secondary outcomes
Sensitivity of 18F-N230A PET/CT for Detecting Renal Pelvic Urothelial Carcinoma
Time frame: Up to 2 months after PET/CT imaging
Specificity of 18F-N230A PET/CT for Detecting Renal Pelvic Urothelial Carcinoma
Time frame: Up to 2 months after PET/CT imaging
Maximum Standardized Uptake Value (SUVmax) of Renal Lesions
Time frame: At the time of PET/CT imaging
Mean Standardized Uptake Value (SUVmean) of Renal Lesions
Time frame: At the time of PET/CT imaging
Lesion-to-Liver Background Uptake Ratio on PET/CT
Time frame: At the time of PET/CT imaging
Lesion-to-Mediastinal Blood Pool Uptake Ratio on PET/CT
Time frame: At the time of PET/CT imaging
Lesion-to-Muscle Uptake Ratio on PET/CT
Time frame: At the time of PET/CT imaging
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 15 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-N230A in people with Renal Cell Carcinoma (RCC) and Renal Pelvic Urothelial Carcinoma, run by Peking University First Hospital 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 4 inclusion and 4 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 15 Oct 2026. 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 Jianhua Zhang (86-10-83572791, zjhjn820@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of 18F-N230A PET/CT (time frame: Up to 2 months after PET/CT imaging). 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 15 Oct 2026.