PSMA-related DiseaseNCT06690970
Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
An observational study of PSMA-related Disease and Prostate Cancer, run by Tianjin Medical University at 3 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PSMA-related Disease, Prostate Cancer, Positron Emission Tomography
- What is being tested?
- 68Ga/18F-PSMA/PSFA
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2020to 1 Dec 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
Qiang Xie, PhD, +8613721108043, ahxq1980@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Guangjie Yang, MD, +8617853297979, ygj_2815@qdu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Haonan Yu, MD, +8613821000597, dreamadam@126.com
About this study
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.
- Conditions
- PSMA-related Disease, Prostate Cancer, Positron Emission Tomography, Metastasis, FAP, Hepatic Cancer
- Being tested
- 68Ga/18F-PSMA/PSFA
- Keywords
- PET/CT, PSMA, FAP
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga/18F-PSMA/PSFADiagnostic test
Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time. Receives: Diagnostic Test: 68Ga/18F-PSMA/PSFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: 30 days
Secondary outcomes (1)
Diagnostic efficacy
The sensitivity, specificity and accuracy of PSMA PET/CT were calculated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Sep 2020
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PSMA-related DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Shaobo Yao, PhD, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690970
- Sponsor's protocol ID
- TJMUGH-04
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
- ClinicalTrials.gov ID
- NCT06690970
- Acronym / sponsor ID
- TJMUGH-04
- Conditions
- PSMA-related Disease, Prostate Cancer, Positron Emission Tomography, Metastasis, FAP, Hepatic Cancer
- Keywords
- PET/CT, PSMA, FAP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | Diagnostic Test: 68Ga/18F-PSMA/PSFAEach subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga/18F-PSMA/PSFAEach subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time. | Diagnostic test | Single Group Assignment |
Primary outcome
Standardized uptake value (SUV)
Time frame: 30 days
Standardized uptake value (SUV) of PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.
1 secondary outcome
Diagnostic efficacy
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 41120594Wang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PSMA-related Disease and Prostate Cancer, run by Tianjin Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haonan Yu, MD (+8613821000597, dreamadam@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06690970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.