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A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in Patients With Locally Advanced and Advanced Renal Cell Carcinoma
Led by Xijing Hospital · Updated on 2026-03-11
300
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
Sponsors
X
Xijing Hospital
Lead Sponsor
A
Air Force Military Medical University, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA PET scans compared to enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to see if 68Ga-PSMA PET can influence treatment decisions for these patients. This prospective, multicenter trial is sponsored by Xijing Hospital and focuses on improving diagnosis and management for renal cancer with metastases. Participants in the study will receive both a 68Ga-PSMA PET scan and an enhanced CT scan simultaneously to compare their abilities to detect cancer spread. This diagnostic approach helps assess the additional value that 68Ga-PSMA PET may provide over standard CT imaging. The study does not involve any masking or placebo groups and includes only patients who meet specific clinical and imaging criteria. During the study, patients will undergo imaging within six weeks after diagnosis, and researchers will track how the 68Ga-PSMA PET results affect treatment choices. The primary measurement is the additional diagnostic value of the PSMA PET compared to CT over two years. Secondary outcomes include how often the PET scan changes treatment decisions. The study monitors patient safety and adherence, with a planned follow-up period to evaluate outcomes until December 2027.
CONDITIONS
Brief Title
68Ga-PSMA PET in the Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with 2017 AJCC renal cell carcinoma stage III or IV
- Suspicious metastases found on contrast-enhanced CT staging
- No known peripheral or central venous problems
- Able to undergo 68Ga PSMA PET/CT imaging within 6 weeks after diagnosis
- Signed informed consent for voluntary participation
You will not qualify if you...
- Age 18 years or younger
- Unable to lie flat for PET/CT examination
- Contraindications for 68Ga PSMA ligands
- History of other malignant tumors in past 2 years or complications affecting test
- Impaired renal function or currently on hemodialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 6 weeks after diagnosis
Participants undergo 68Ga PSMA PET and enhanced CT imaging to assess renal cell carcinoma and suspicious metastases.
1 visit (in-person)
Duration - 2 years
Participants are followed for up to 2 years to evaluate the diagnostic value of 68Ga PSMA PET / CT and changes in treatment decision-making.
Follow-up visits as needed
Trial Site Locations
Total: 9 locations
1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
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2
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
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3
Qinghai University Affiliated Hospital
Xining, Qinghai, China
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4
Xijing Hospital
Xi'an, Shaan'xi, China, 710032
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5
Weinan Central Hospital
Weinan, Shaanxi, China
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6
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
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7
Xijing 986 Hospital
Xi'an, Shaanxi, China
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8
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
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9
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, China
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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