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Clinical Trial NCT06690970 for PSMA-related Disease, Prostate Cancer, Positron Emission Tomography, Metastasis, FAP is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Tianjin Medical UniversityProstate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients 500
Clinical Trial NCT06690970 is an observational study for PSMA-related Disease, Prostate Cancer, Positron Emission Tomography, Metastasis, FAP that is recruiting. It started on 1 September 2020 with plans to enroll 500 participants. Led by Tianjin Medical University, it is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 11 August 2025.
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.
Official Title
Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
Conditions
PSMA-related DiseaseProstate CancerPositron Emission TomographyMetastasisFAPPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- TJMUGH-04
NCT ID Number
Start Date (Actual)
2020-09-01
Last Update Posted
2025-08-11
Completion Date (Estimated)
2027-12-01
Enrollment (Estimated)
500
Study Type
Observational
Status
Recruiting
Keywords
PET/CT
PSMA
FAP
PSMA
FAP
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Single Group Assignment Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time. | 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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Standardized uptake value (SUV) | Standardized uptake value (SUV) of PSMA for each target lesion of subject or suspected primary tumor or/and metastasis. | 30 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Diagnostic efficacy | The sensitivity, specificity and accuracy of PSMA PET/CT were calculated. | 30 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- (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.
- (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.
Tianjin Medical University378 active studies to exploreTianjin Medical University General Hospital378 active studies to exploreStudy Responsible Party
Shaobo Yao, PhD, Principal Investigator, Prof., Tianjin Medical University
Study Central Contact
Contact: Haonan Yu, MD, +8613821000597, [email protected]
2 Study Locations in 1 Countries
Anhui
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, 230000, China
Qiang Xie, PhD, Contact, +8613721108043, [email protected]
Recruiting
Tianjin Municipality
Tianjin Medical University General Hospital, Tianjin, Tianjin Municipality, 300052, China
Haonan Yu, MD, Contact, +8613821000597, [email protected]
Recruiting