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

T

Tianjin Medical University

Status

Enrolling

Conditions

FAP
PSMA-related Disease
Metastasis
Positron Emission Tomography
Prostate Cancer

Treatments

Diagnostic Test: 68Ga/18F-PSMA/PSFA

Study type

Observational

Funder types

Other

Identifiers

NCT06690970
TJMUGH-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Single Group Assignment
Description:
Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time.
Treatment:
Diagnostic Test: 68Ga/18F-PSMA/PSFA

Trial contacts and locations

2

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Central trial contact

Haonan Yu, MD

Data sourced from clinicaltrials.gov

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