68Ga-PSMA PET in the Renal Cell Carcinoma

March 8, 2026 updated by: Qin Weijun, Xijing Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Wei Zhang, MD.
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
        • Principal Investigator:
          • Zhiyong Lv, MD.
    • Qinghai
      • Xining, Qinghai, China
        • Recruiting
        • Qinghai University Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Guojun Chen, MD.
    • Shaan'xi
      • Xi'an, Shaan'xi, China, 710032
    • Shaanxi
      • Weinan, Shaanxi, China
        • Recruiting
        • Weinan Central Hospital
        • Contact:
        • Principal Investigator:
          • Weihong Zhao, MD.
      • Xi'an, Shaanxi, China
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Yi Sun, MD.
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xijing 986 Hospital
        • Contact:
        • Principal Investigator:
          • Wuhe Zhang, MD.
      • Xianyang, Shaanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Wei Zheng, MD.
      • Yan’an, Shaanxi, China
        • Recruiting
        • Affiliated Hospital of Yan'an University
        • Contact:
        • Principal Investigator:
          • Jixue Gao, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA PET Arm
The PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer.
Diagnostic test: PSMA PET
PSMA PET may have influence on the clinical decision-making of the patients with renal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

LanZhou University
Shaanxi Provincial People's Hospital
Air Force Military Medical University, China
General Hospital of Ningxia Medical University
Affiliated Hospital of Qinghai University
Weinan Central Hospital
Yan'an University Affiliated Hospital
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20212033-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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