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Clinical Trials/NCT05422105
NCT05422105
Recruiting
Not Applicable

Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer

Primo Biotechnology Co., Ltd2 sites in 1 country230 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
18F-PSMA-1007
Conditions
Prostate Cancer
Sponsor
Primo Biotechnology Co., Ltd
Enrollment
230
Locations
2
Primary Endpoint
Diagnostic Performance
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the 18F-PSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of 18F-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Primo Biotechnology Co., Ltd
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Suspected Prostate Cancer

Intervention: 18F-PSMA-1007

Outcomes

Primary Outcomes

Diagnostic Performance

Time Frame: 7-14 days after PET/CT

Sensitivity, Specificity, NPV, PPV

Study Sites (2)

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