Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
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: 68Ga/18F-PSMA/PSFA.
- Who it may be relevant to
- Registry conditions: PSMA-related Disease, Prostate Cancer, Positron Emission Tomography, Metastasis. Basic parameters: 18 years — 80 years · All.
- 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 →
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Overview
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.
Interventions
- Diagnostic test 68Ga/18F-PSMA/PSFA
Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time.
Primary outcome measures
- Standardized uptake value (SUV) [Time frame: 30 days]
Secondary outcome measures (1)
- Diagnostic efficacy [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- The First Affiliated Hospital of University of Science and Technology of China — Hefei
- Tianjin Medical University General Hospital — Tianjin
Publications
- Wang X, Wang M, Chen Y, Jian R, Yu H, Zhang X, Zhang J, Yao S, Du J, Cui M. Preclinical evaluation and first-in-human study of 68Ga- and Al18F-Labeled PSMA/FAP bispecific tracers for prostate cancer imaging. Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2489-2501. doi: 10.1007/s00259-025-07591-7. Epub 2025 Oct 22. PMID 41120594
Identifiers
NCT: NCT06690970 · TJMUGH-04