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RecruitingNCT04987086Updated Mar 11, 2026

68Ga-PSMA PET in the Renal Cell Carcinoma

An interventional study of PSMA PET in Renal Cancer, Metastases and PSMA PET, sponsored by Xijing Hospital. Recruiting at 9 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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

02

Conditions studied

  • Renal Cancer
  • Metastases
  • PSMA PET

Keywords

  • advnaced renal cancer
  • PSMA PET
  • metastases
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 300 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testPSMA PET

    PSMA PET may have influence on the clinical decision-making of the patients with renal cancer

06

What researchers measure

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.

    Time frame: 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.

    Time frame: 2 years

07

Study locations

9 of 9 sites recruiting
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu, China
    • Wei Zhang · Contact · 1531769428@qq.com · +86 18700919857
    • Wei Zhang, MD. · Principal investigator
    Recruiting
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia, China
    • Zhiyong Lv, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Zhiyong Lv, MD. · Principal investigator
    Recruiting
  • Qinghai University Affiliated Hospital
    Xining, Qinghai, China
    • Guojun Chen, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Guojun Chen, MD. · Principal investigator
    Recruiting
  • Xijing Hospital
    Xi'an, Shaan'xi 710032, China
    Recruiting
  • Weinan Central Hospital
    Weinan, Shaanxi, China
    • Weihong Zhao, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Weihong Zhao, MD. · Principal investigator
    Recruiting
  • Shaanxi Provincial People's Hospital
    Xi'an, Shaanxi, China
    • Yi Sun, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Yi Sun, MD. · Principal investigator
    Recruiting
  • Xijing 986 Hospital
    Xi'an, Shaanxi, China
    • Wuhe Zhang, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Wuhe Zhang, MD. · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
    Xianyang, Shaanxi, China
    • Wei Zheng, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Wei Zheng, MD. · Principal investigator
    Recruiting
  • Affiliated Hospital of Yan'an University
    Yan’an, Shaanxi, China
    • Jixue Gao, MD. · Contact · 1531769428@qq.com · +86 18700919857
    • Jixue Gao, MD. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04987086
Lead sponsor
Xijing Hospital
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
Qin Weijun (Professor and Director, Department of Urology, Xijing Hospital) — Principal investigator
First posted
Aug 3, 2021
Start date
Jun 1, 2021
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Mar 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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