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Recruiting NCT04987086

68Ga-PSMA PET in the Renal Cell Carcinoma

No phase Interventional Renal Cancer Metastases PSMA PET

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSMA PET.
Who it may be relevant to
Registry conditions: Renal Cancer, Metastases, PSMA PET. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 9 centers
  • The First Hospital of Lanzhou University — Lanzhou
  • General Hospital of Ningxia Medical University — Yinchuan
  • Qinghai University Affiliated Hospital — Xining
  • Xijing Hospital — Xi'an
  • Weinan Central Hospital — Weinan
  • Shaanxi Provincial People's Hospital — Xi'an
  • Xijing 986 Hospital — Xi'an
  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine — Xianyang
  • … and 1 more center

Identifiers

NCT: NCT04987086 · KY20212033-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗