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NCT Number: NCT04987086

68Ga-PSMA PET in the 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

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Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes PSMA PET Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Lanzhou University, Lanzhou, Gansu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PSMA PET

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

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

Registry information

Official study title

A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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