68Ga-PSMA PET in the Renal Cell Carcinoma
A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma
1 other identifier
interventional
300
1 country
9
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 11, 2026
March 1, 2026
5.5 years
July 11, 2021
March 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
2 years
Study Arms (1)
PSMA PET Arm
EXPERIMENTALThe PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer.
Interventions
PSMA PET may have influence on the clinical decision-making of the patients with renal cancer
Eligibility Criteria
You may qualify if:
- 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;
- Ga 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
- Air Force Military Medical University, Chinacollaborator
- Shaanxi Provincial People's Hospitalcollaborator
- Yan'an University Affiliated Hospitalcollaborator
- Weinan Central Hospitalcollaborator
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicinecollaborator
- LanZhou Universitycollaborator
- Affiliated Hospital of Qinghai Universitycollaborator
- General Hospital of Ningxia Medical Universitycollaborator
Study Sites (9)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Xijing Hospital
Xi'an, Shaan'xi, 710032, China
Weinan Central Hospital
Weinan, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Xijing 986 Hospital
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director, Department of Urology
Study Record Dates
First Submitted
July 11, 2021
First Posted
August 3, 2021
Study Start
June 1, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share