ClinicalTrials.gg
RecruitingNCT06690970Updated Sep 8, 2026

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

An observational study in PSMA-related Disease, Prostate Cancer and Positron Emission Tomography, sponsored by Tianjin Medical University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Tianjin Medical University · Observational

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study 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.).

Read the 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.

02

Conditions studied

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

Keywords

  • PET/CT
  • PSMA
  • FAP
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

(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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

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 .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • Single Group Assignment

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

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

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.

06

What researchers measure

Primary outcomes

  1. Standardized uptake value (SUV)

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

    Time frame: 30 days

Secondary outcomes

  1. Diagnostic efficacy

    The sensitivity, specificity and accuracy of PSMA PET/CT were calculated.

    Time frame: 30 days

07

Study locations

3 of 3 sites recruiting
08

References and documents

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. PubMed 41120594 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06690970
Lead sponsor
Tianjin Medical University
Collaborators
Tianjin Medical University General Hospital
Responsible party
Shaobo Yao, PhD (Prof., Tianjin Medical University) — Principal investigator
First posted
Nov 15, 2024
Start date
Sep 1, 2020
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Haonan Yu, MD
Contact
dreamadam@126.com
+8613821000597

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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