Renal CancerNCT04987086
68Ga-PSMA PET in the Renal Cell Carcinoma
A study testing PSMA PET in people with Renal Cancer and Metastases, run by Xijing Hospital at 9 sites in China.
Trial summary
The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Cancer, Metastases, PSMA PET
- What is being tested?
- PSMA PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jun 2021to 1 Dec 2027
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2017 AJCC renal cell carcinoma TNM stage III, IV lesions;
- In contrast-enhanced CT staging, suspicious metastases were found;
- There were no known peripheral or central venous problems;
- 68Ga PSMA PET / CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma;
- Signed the informed consent form of voluntary participation in clinical trials.
Who cannot join
- Age ≤ 18 years old;
- Can't stand lying flat in PET / CT examination;
- There are contraindications for 68Ga PSMA ligands;
- In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test;
- Renal function is impaired or hemodialysis is in progress.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Wei Zhang, +86 18700919857, 1531769428@qq.com
Wei Zhang, MD.
- Recruiting
Weinan Central Hospital
Weinan, Shaanxi
Weihong Zhao, MD., +86 18700919857, 1531769428@qq.com
Weihong Zhao, MD.
- Recruiting
Xijing Hospital
Xi'an, Shaan'xi, 710032
Yanyan Jia, +86 029 8477 1794, jiayanyan-2004@hotmail.com
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Yi Sun, MD., +86 18700919857, 1531769428@qq.com
Yi Sun, MD.
- Recruiting
Xijing 986 Hospital
Xi'an, Shaanxi
Wuhe Zhang, MD., +86 18700919857, 1531769428@qq.com
Wuhe Zhang, MD.
- Recruiting
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi
Wei Zheng, MD., +86 18700919857, 1531769428@qq.com
Wei Zheng, MD.
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai
Guojun Chen, MD., +86 18700919857, 1531769428@qq.com
Guojun Chen, MD.
- Recruiting
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi
Jixue Gao, MD., +86 18700919857, 1531769428@qq.com
Jixue Gao, MD.
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Zhiyong Lv, MD., +86 18700919857, 1531769428@qq.com
Zhiyong Lv, MD.
About this study
Official title: A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma
The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma
- Conditions
- Renal Cancer, Metastases, PSMA PET
- Being tested
- PSMA PET
- Keywords
- advnaced renal cancer, PSMA PET, metastases
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PETDiagnostic test
PSMA PET may have influence on the clinical decision-making of the patients with renal cancer
| Study group | Role | What they receive |
|---|---|---|
| PSMA PET Arm | Experimental | The PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer. Receives: Diagnostic Test: PSMA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional diagnostic value of 68Ga PSMA PET / CT compared with CT in patients with locally advanced and advanced renal cell carcinoma
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA PET/CT compared with enhanced CT in diagnosing locally advanced and advanced renal cell carcinoma metastases in clinical practice. If the diagnostic performance of 68Ga PSMA PET / CT is better than enhanced CT, it may have additional diagnostic value in in locally advanced and advanced renal cell carcinoma.
Measured: 2 years
Secondary outcomes (1)
The changes of treatment decision-making in patients with locally advanced and advanced renal cell carcinoma by 68Ga PSMA PET / CT.
The impact of 68Ga-PSMA PET/CT on clinical decisions in patients with locally advanced (Stage III) and advanced renal cell carcinoma (Stage IV) were evaluated by a multidisciplinary prostate cancer therapy team. The clinical decisions were made according to the EAU and NCCN guidelines. The patients with locally advanced (Stage III) has no metastases and advanced renal cell carcinoma (Stage IV) may have oligometastatic disease or metastatic disease. For the patients with locally advanced renal cell carcinoma (Stage III), radical nephrectomy or partial nephrectomy is appropriate. For the patients with advanced renal cell carcinoma (Stage IV), the patients with potentially surgically resectable RCC can receive surgery and the patients with unresectable RCC need to receive systemic therapy and rediotherapy. The different staging performance of enhanced CT and 68Ga-PSMA PET/CT may have impact on patients with locally advanced and advanced renal cell carcinoma.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jun 2021
- Primary completion1 Dec 2026 (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 Renal CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Shaanxi Provincial People's Hospital, Yan'an University Affiliated Hospital, Weinan Central Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, LanZhou University, Affiliated Hospital of Qinghai University, General Hospital of Ningxia Medical University
- Responsible party
- Principal investigator, Qin Weijun, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987086
- Sponsor's protocol ID
- KY20212033-F-1
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2021
- Last updated
- 11 Mar 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04987086
- Acronym / sponsor ID
- KY20212033-F-1
- Conditions
- Renal Cancer, Metastases, PSMA PET
- Keywords
- advnaced renal cancer, PSMA PET, metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Shaanxi Provincial People's Hospital, Yan'an University Affiliated Hospital, Weinan Central Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, LanZhou University, Affiliated Hospital of Qinghai University, General Hospital of Ningxia Medical University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Aug 2021 (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 primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA PET Arm | Experimental | Diagnostic Test: PSMA PETThe PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 2017 AJCC renal cell carcinoma TNM stage III, IV lesions;
- In contrast-enhanced CT staging, suspicious metastases were found;
- There were no known peripheral or central venous problems;
- 68Ga PSMA PET / CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma;
- Signed the informed consent form of voluntary participation in clinical trials.
Key exclusion criteria (5 listed)
- Age ≤ 18 years old;
- Can't stand lying flat in PET / CT examination;
- There are contraindications for 68Ga PSMA ligands;
- In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test;
- Renal function is impaired or hemodialysis is in progress.
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 |
|---|---|---|
| PSMA PETPSMA PET may have influence on the clinical decision-making of the patients with renal cancer | Diagnostic test | PSMA PET Arm |
Primary outcome
Additional diagnostic value of 68Ga PSMA PET / CT compared with CT in patients with locally advanced and advanced renal cell carcinoma
Time frame: 2 years
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA PET/CT compared with enhanced CT in diagnosing locally advanced and advanced renal cell carcinoma metastases in clinical practice. If the diagnostic performance of 68Ga PSMA PET / CT is better than enhanced CT, it may have additional diagnostic value in in locally advanced and advanced renal cell carcinoma.
1 secondary outcome
The changes of treatment decision-making in patients with locally advanced and advanced renal cell carcinoma by 68Ga PSMA PET / CT.
Time frame: 2 years
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 11 Mar 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET in people with Renal Cancer and Metastases, run by Xijing Hospital at 9 sites 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 5 inclusion and 5 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional diagnostic value of 68Ga PSMA PET / CT compared with CT in patients with locally advanced and advanced renal cell carcinoma (time frame: 2 years). 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 11 Mar 2026.