PSMAEarly Phase 1NCT06387381
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
A Early Phase 1 study testing 68Ga-PSFA in people with PSMA and FAP, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PSMA, FAP, Positron-Emission Tomography
- What is being tested?
- 68Ga-PSFA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 31 Dec 2026
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Signed informed consent.
- Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).
Who cannot join
- Patients with non-malignant disease.
- Patients with pregnancy.
- The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
- Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
- Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Xiaoyang Zhang, PhD, 023-89011755, zhangxy@mail.bnu.edu.cn
About this study
As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases.
- Conditions
- PSMA, FAP, Positron-Emission Tomography
- Being tested
- 68Ga-PSFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSFADrug
Each subject receives a single intravenous injection of 68Ga-PSFA.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSFA | Experimental | Patients will receive a single administration of 68Ga-PSFA. Receives: Drug: 68Ga-PSFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
The sensitivity, specificity, and accuracy of 68Ga-PSFA PET
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start20 May 2024
- Primary completion30 Apr 2025
- Study completion31 Dec 2026 (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 PSMAStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoyang Zhang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387381
- Sponsor's protocol ID
- CYYY-KY-2024-048-01
- Status last verified
- May 2025
- First submitted
- 24 Apr 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Zhang X, Zhang X, Guan L, Gao X, Xu L, Pang H, Du J, Zhang J, Cui M. Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer. Eur J Nucl Med Mol Imaging. 2025 Feb;52(3):1166-1176. doi: 10.1007/s00259-024-06965-7. Epub 2024 Nov 9.
PubMed 39520516
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
- ClinicalTrials.gov ID
- NCT06387381
- Acronym / sponsor ID
- CYYY-KY-2024-048-01
- Conditions
- PSMA, FAP, Positron-Emission Tomography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 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.
As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSFA | Experimental | Drug: 68Ga-PSFAPatients will receive a single administration of 68Ga-PSFA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Signed informed consent.
- Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).
Key exclusion criteria (5 listed)
- Patients with non-malignant disease.
- Patients with pregnancy.
- The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
- Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
- Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
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-PSFAEach subject receives a single intravenous injection of 68Ga-PSFA. | Drug | 68Ga-PSFA |
Primary outcome
Diagnostic efficacy
Time frame: 15 days
The sensitivity, specificity, and accuracy of 68Ga-PSFA PET
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 4 Jun 2025.
- Derived from this study: PubMed 39520516Wang X, Zhang X, Zhang X, Guan L, Gao X, Xu L, Pang H, Du J, Zhang J, Cui M. Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer. Eur J Nucl Med Mol Imaging. 2025 Feb;52(3):1166-1176. doi: 10.1007/s00259-024-06965-7. Epub 2024 Nov 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-PSFA in people with PSMA and FAP, run by First Affiliated Hospital of Chongqing Medical University at 1 site 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 3 inclusion and 5 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoyang Zhang, PhD (86 023-89011755, zhangxy@mail.bnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: 15 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 NCT06387381, 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 4 Jun 2025.