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Clinical Trials/NCT06723665
NCT06723665
Enrolling By Invitation
Not Applicable

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

Affiliated Hospital of Jiangnan University1 site in 1 country50 target enrollmentJanuary 25, 2024

Overview

Phase
Not Applicable
Intervention
18F-PSMA-1007
Conditions
Prostate Cancer
Sponsor
Affiliated Hospital of Jiangnan University
Enrollment
50
Locations
1
Primary Endpoint
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
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Affiliated Hospital of Jiangnan University
Responsible Party
Principal Investigator
Principal Investigator

Chunjing Yu

Director

Affiliated Hospital of Jiangnan University

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.

Arms & Interventions

18F-PSMA-1007

Subjects: Patients with suspected or diagnosed prostate cancer, or biochemical recurrence of prostate cancer. Over 40 years old (including 40 years old); Informed consent and access to follow-up; To exclude patients who are difficult to receive further diagnosis and treatment because of their serious condition. PSMA PET/CT was reviewed 7 days and 3 months after surgery. All patients were followed up once every 3 months to understand the progression and survival of the lesions.

Intervention: 18F-PSMA-1007

18F-FDG

The corresponding patients underwent PSMAPET/CT examination within one week before and after routine 18F-FDGPCT/CT imaging (control examination). PCT/CT whole body scan was performed 45min-1h after intravenous injection of the developer, and the image processing was as usual.

Intervention: 18F-FDG

Outcomes

Primary Outcomes

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

For patients receiving 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT imaging was performed, and image visual analysis, semi-quantitative analysis and prognostic study were performed on PET/CT images. To evaluate the diagnosis, staging and prognosis of 18F-PSMA-1007

Study Sites (1)

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