Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients

Recruiting

• Conditions: PSMA-related Disease; Prostate Cancer; Positron Emission Tomography; Metastasis

• Registration Number: NCT06690970
• Lead Sponsor: Tianjin Medical University

Brief Summary

To evaluate the potential usefulness of 68Ga/18F-PSMA 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 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 PET/CT were calculated.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	30 days	Standardized uptake value (SUV) of PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary Outcome Measures

Name	Time	Method
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of PSMA PET/CT were calculated.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China