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Enrolling by invitation NCT06723665

The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients

No phase Interventional Prostate Cancer

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: 18F-PSMA-1007, 18F-FDG.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 40 years — 75 years · Male.
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 →

Overview

micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.

Detailed description

1. Visual analysis of images: describe the location, size, shape and degree of uptake of lesions; 2. Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI); 3. Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified; 4. Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging; 5. Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.

Interventions

  • Drug 18F-PSMA-1007
    18F-PSMA-1007 is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg
  • Drug 18F-FDG
    18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg

Primary outcome measures

  • 18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.

Exclusion criteria

Patients who did not meet the requirements as assessed by the investigator.

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Affiated Hospital of Jiangnan University — Wuxi

Identifiers

NCT: NCT06723665 · LS2024279

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗