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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06690970

Enrollment

500

Registered

2024-11-15

Start date

2020-09-01

Completion date

2027-12-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FAP, Hepatic Cancer, Metastasis, Positron Emission Tomography, Prostate Cancer, PSMA-related Disease

Keywords

PET/CT, PSMA, FAP

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 (prostate cancer, hepatic cancer, etc.).

Detailed description

Subjects with various PSMA-related disease patients (prostate cancer, hepatic cancer, etc.) 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_TEST68Ga/18F-PSMA/PSFA

Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of PSMA PET/CT were calculated.

Countries

China

Contacts

CONTACTHaonan Yu, MD

dreamadam@126.com+8613821000597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026