Prostate CancerNCT07639801
68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors
A study testing 68Ga-FAPI-PSMA, 68Ga-PSMA-617 and 68Ga-FAPI-04 in people with Prostate Cancer and Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute.
Trial summary
This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prostate Cancer, Hepatocellular Carcinoma, Ovarian Cancer
- What is being tested?
- 68Ga-FAPI-PSMA, 68Ga-PSMA-617 and 68Ga-FAPI-04
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to 31 Dec 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Patients with suspected or confirmed solid tumors (e.g., prostate cancer, hepatocellular carcinoma, ovarian cancer, or endometrial cancer)
- Patients scheduled to undergo tumor biopsy or surgical treatment within 2 months
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate hematologic and organ function:
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- White blood cell count ≥ 4.0 × 10^9/L or neutrophils ≥ 1.5 × 10^9/L
- Platelet count ≥ 100 × 10^9/L
- Hemoglobin ≥ 90 g/L
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- ALT/AST ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
- Creatinine ≤ 1.5 × ULN
- At least one measurable lesion according to RECIST 1.1 criteria
- Ability to understand the study procedures and willingness to sign written informed consent
Who cannot join
- Severe hepatic or renal dysfunction
- Inability to remain in a supine position for approximately 30 minutes during PET/CT scanning
- Refusal or inability to participate in the clinical study
- Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET/CT for the Diagnosis and Staging of Solid Tumors
This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection.
In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.
- Conditions
- Prostate Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Solid Tumors, Endometrial Cancer, FAPI
- Being tested
- 68Ga-FAPI-PSMA, 68Ga-PSMA-617, 68Ga-FAPI-04
- Medical subject headings
- Prostatic Neoplasms, Carcinoma, Hepatocellular, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-PSMARadiation
Participants will receive an intravenous injection of the investigational PET tracer 68Ga-FAPI-PSMA (0.1-0.15 mCi/kg). Whole-body PET/CT imaging will be performed approximately 1 hour after injection. Delayed imaging at 2-4 hours may be performed when necessary. Imaging results will be used to evaluate tracer uptake in tumor lesions and to assess the diagnostic performance of the dual-targeted tracer.
68Ga-PSMA-617Radiation
Participants will receive an intravenous injection of the PET tracer 68Ga-PSMA-617 (0.1-0.15 mCi/kg) followed by PET/CT imaging approximately 1 hour after administration. This imaging serves as a comparator to evaluate the diagnostic performance of the investigational tracer 68Ga-FAPI-PSMA.
68Ga-FAPI-04Radiation
Participants may undergo PET/CT imaging using the PET tracer 68Ga-FAPI-04 (0.1-0.15 mCi/kg) with imaging performed approximately 1 hour after injection. This imaging will serve as a comparator for assessing the diagnostic performance of 68Ga-FAPI-PSMA PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-PSMA PET/CT Imaging | Experimental | Participants with suspected or confirmed solid tumors will undergo PET/CT imaging using the investigational tracer 68Ga-FAPI-PSMA. Imaging findings will be compared with PET/CT performed using standard tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04 to evaluate the diagnostic performance of the dual-targeted tracer. Receives: Radiation: 68Ga-FAPI-PSMA; Radiation: 68Ga-PSMA-617; Radiation: 68Ga-FAPI-04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value (SUV) of Tumor Lesions
The standardized uptake value (SUV) of target or suspected tumor lesions measured on 68Ga-FAPI-PSMA PET/CT imaging. SUV values will be used to evaluate tracer uptake and diagnostic performance in solid tumors.
Measured: 1-4 hours after injection
Secondary outcomes (3)
Tumor-to-Background Ratio (TBR) of Target Tumor Lesions on 68Ga-FAPI-PSMA PET/CT
The tumor-to-background ratio (TBR) will be calculated as the SUVmax of the target tumor lesion divided by the SUVmean of the corresponding background normal tissue. TBR will be used to quantitatively assess lesion contrast on 68Ga-FAPI-PSMA PET/CT.
Measured: 1-4 hours after 68Ga-FAPI-PSMA injection
Mean Standardized Uptake Value (SUVmean) of Normal Organs on 68Ga-FAPI-PSMA PET/CT
The mean standardized uptake value (SUVmean) of normal organs and tissues, including but not limited to the liver, spleen, kidneys, lungs, bone marrow, muscle, and blood pool, will be measured on 68Ga-FAPI-PSMA PET/CT images to characterize tracer biodistribution.
Measured: 1 to 4 hours after 68Ga-FAPI-PSMA injection
Number of Metastatic Lesions Detected by 68Ga-FAPI-PSMA PET/CT
The number of metastatic lesions detected by 68Ga-FAPI-PSMA PET/CT will be recorded for each participant. Lesion detection will be compared with standard PET tracers, including 68Ga-PSMA-617 or 68Ga-FAPI-04, when available, and/or with conventional imaging or pathological findings according to the study protocol.
Measured: From the date of 68Ga-FAPI-PSMA PET/CT imaging to completion of reference-standard assessment, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639801
- Sponsor's protocol ID
- 2023KT107-ZY02
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET/CT for the Diagnosis and Staging of Solid Tumors
- ClinicalTrials.gov ID
- NCT07639801
- Acronym / sponsor ID
- 2023KT107-ZY02
- Conditions
- Prostate Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Solid Tumors, Endometrial Cancer, FAPI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2026 (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.
This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection.
In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-PSMA PET/CT Imaging | Experimental | Radiation: 68Ga-FAPI-PSMA, Radiation: 68Ga-PSMA-617, Radiation: 68Ga-FAPI-04Participants with suspected or confirmed solid tumors will undergo PET/CT imaging using the investigational tracer 68Ga-FAPI-PSMA. Imaging findings will be compared with PET/CT performed using standard tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04 to evaluate the diagnostic performance of the dual-targeted tracer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18-75 years
Key exclusion criteria (5 listed)
- Severe hepatic or renal dysfunction
- Inability to remain in a supine position for approximately 30 minutes during PET/CT scanning
- Refusal or inability to participate in the clinical study
- Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for 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-FAPI-PSMAParticipants will receive an intravenous injection of the investigational PET tracer 68Ga-FAPI-PSMA (0.1-0.15 mCi/kg). Whole-body PET/CT imaging will be performed approximately 1 hour after injection. Delayed imaging at 2-4 hours may be performed when necessary. Imaging results will be used to evaluate tracer uptake in tumor lesions and to assess the diagnostic performance of the dual-targeted tracer. | Radiation | 68Ga-FAPI-PSMA PET/CT Imaging |
| 68Ga-PSMA-617Participants will receive an intravenous injection of the PET tracer 68Ga-PSMA-617 (0.1-0.15 mCi/kg) followed by PET/CT imaging approximately 1 hour after administration. This imaging serves as a comparator to evaluate the diagnostic performance of the investigational tracer 68Ga-FAPI-PSMA. | Radiation | 68Ga-FAPI-PSMA PET/CT Imaging |
| 68Ga-FAPI-04Participants may undergo PET/CT imaging using the PET tracer 68Ga-FAPI-04 (0.1-0.15 mCi/kg) with imaging performed approximately 1 hour after injection. This imaging will serve as a comparator for assessing the diagnostic performance of 68Ga-FAPI-PSMA PET/CT. | Radiation | 68Ga-FAPI-PSMA PET/CT Imaging |
Primary outcome
Standardized Uptake Value (SUV) of Tumor Lesions
Time frame: 1-4 hours after injection
The standardized uptake value (SUV) of target or suspected tumor lesions measured on 68Ga-FAPI-PSMA PET/CT imaging. SUV values will be used to evaluate tracer uptake and diagnostic performance in solid tumors.
3 secondary outcomes
Tumor-to-Background Ratio (TBR) of Target Tumor Lesions on 68Ga-FAPI-PSMA PET/CT
Time frame: 1-4 hours after 68Ga-FAPI-PSMA injection
Mean Standardized Uptake Value (SUVmean) of Normal Organs on 68Ga-FAPI-PSMA PET/CT
Time frame: 1 to 4 hours after 68Ga-FAPI-PSMA injection
Number of Metastatic Lesions Detected by 68Ga-FAPI-PSMA PET/CT
Time frame: From the date of 68Ga-FAPI-PSMA PET/CT imaging to completion of reference-standard assessment, up to 2 months
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI-PSMA, 68Ga-PSMA-617 and 68Ga-FAPI-04 in people with Prostate Cancer and Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute.
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 14 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: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 yifei pei (+86 15602222734, peiyfiei0523@163.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) of Tumor Lesions (time frame: 1-4 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.