Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tianjin Medical University
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Standardized uptake value (SUV)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
To evaluate the potential usefulness of 68Ga/18F-PSMA/PSFA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various PSMA-related disease patients.
Detailed Description
Subjects with various PSMA-related disease patients underwent 68Ga/18F-PSMA/PSFA PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-PSMA/PSFA PET/CT were calculated.
Investigators
Shaobo Yao, PhD
Prof.
Tianjin Medical University
Eligibility Criteria
Inclusion Criteria
- •(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria
- •(i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Outcomes
Primary Outcomes
Standardized uptake value (SUV)
Time Frame: 30 days
Standardized uptake value (SUV) of PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.
Secondary Outcomes
- Diagnostic efficacy(30 days)