Solid TumorNCT07776899
Clinical Applications of FAPI PET in Solid Tumors
A study testing FAPI-RuiJ and FAPI-04 in people with Solid Tumor, run by Ruijin Hospital at 1 site in China.
Trial summary
The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- FAPI-RuiJ and FAPI-04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2026to 31 Mar 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years, regardless of gender.
- Participants with suspected, confirmed, or suspected recurrent solid tumors.
- Participants who agree to participate in this clinical trial and provide written informed consent.
- Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process.
- No plans for pregnancy within 6 months.
Who cannot join
- Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency.
- Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures.
- Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions.
- Pregnant or breastfeeding women.
- Patients with poor compliance.
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Ying Miao, 0086-13671921521, myada821@hotmail.com
About this study
Official title: Clinical Applications of Novel FAPI PET in Diverse Solid Tumors
The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
Read the detailed description
This prospective study is designed to evaluate and compare the PET/CT or PET/MR imaging characteristics of two fibroblast activation protein (FAP)-targeted tracers-the novel tracer FAPI-RuiJ and the reference tracer FAPI-04-across a diverse range of solid tumors. All enrolled patients will undergo paired PET imaging with both FAPI-RuiJ and FAPI-04. For each tracer, semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, tumor-to-background ratio [TBR]）will be measured and compared. Biodistribution characteristics of FAPI-RuiJ in normal organs will be assessed to determine its in vivo metabolic profile. Using histopathology or imaging follow-up as the reference standard, the diagnostic performance of FAPI-RuiJ PET will be compared with that of FAPI-04 PET, with evaluation metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC). Correlation analyses will be performed between PET parameters and clinicopathological characteristics, including tumor markers, pathological subtype, and immunohistochemical markers.The study is expected to provide a novel molecular imaging tool to support early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
- Conditions
- Solid Tumor
- Being tested
- FAPI-RuiJ, FAPI-04
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI-RuiJDiagnostic test
A novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
FAPI-04Diagnostic test
A FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day | Experimental | Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-RuiJ administered first and FAPI-04 on a separate day (interval: 1-7 days). For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time. All images will be independently reviewed by two blinded nuclear medicine physicians. Histopathology or imaging follow-up serves as the reference standard. Receives: Diagnostic Test: FAPI-RuiJ; Diagnostic Test: FAPI-04 |
| Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day | Experimental | Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-04 administered first and FAPI-RuiJ on a separate day (interval: 1-7 days). For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time. All images will be independently reviewed by two blinded nuclear medicine physicians. Histopathology or imaging follow-up serves as the reference standard. Receives: Diagnostic Test: FAPI-RuiJ; Diagnostic Test: FAPI-04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET
Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard.
Measured: Through study completion, an average of 3 years
AUC of FAPI-RuiJ PET versus FAPI-04 PET
Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard.
Measured: Through study completion, an average of 3 years
Secondary outcomes (4)
Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Semi-quantitative comparison of standardized uptake value (SUV) parameters (SUVmax, SUVmean, and SUVpeak) between the two tracers in solid tumor lesions.
Measured: At the time of PET/CT scan
Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Semi-quantitative comparison of TBR between the two tracers in solid tumor lesions. TBR is calculated as the ratio of tumor SUVmax to background SUVmean.
Measured: At the time of PET/CT scan
Biodistribution characteristics of FAPI-RuiJ PET in normal organs
Quantitative assessment of FAPI-RuiJ tracer biodistribution in major normal organs (including brain, submandibular gland, thyroid, lung, descending aorta, heart, liver, pancreas, stomach, spleen, kidney, bone, muscle, small intestine, gallbladder) measured by SUVmean and SUVmax on PET/CT images using ROI-based analysis.
Measured: At the time of PET/CT scan
Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors
Correlation analysis between FAPI-RuiJ PET semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, TBR and clinicopathological characteristics, including tumor markers (e.g., CEA, CA19-9, AFP, etc.), pathological subtype, and immunohistochemical markers (e.g., Ki-67, PD-L1, EGFR, etc.). Correlations will be assessed using Spearman's rank correlation coefficient (ρ), with statistical significance set at p < 0.05.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start2 Jul 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biao Li, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776899
- Sponsor's protocol ID
- 2026 CER 311
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Novel FAPI PET in Diverse Solid Tumors
- ClinicalTrials.gov ID
- NCT07776899
- Acronym / sponsor ID
- 2026 CER 311
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 20 Aug 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.
The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
Detailed description
This prospective study is designed to evaluate and compare the PET/CT or PET/MR imaging characteristics of two fibroblast activation protein (FAP)-targeted tracers-the novel tracer FAPI-RuiJ and the reference tracer FAPI-04-across a diverse range of solid tumors. All enrolled patients will undergo paired PET imaging with both FAPI-RuiJ and FAPI-04. For each tracer, semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, tumor-to-background ratio [TBR]）will be measured and compared. Biodistribution characteristics of FAPI-RuiJ in normal organs will be assessed to determine its in vivo metabolic profile. Using histopathology or imaging follow-up as the reference standard, the diagnostic performance of FAPI-RuiJ PET will be compared with that of FAPI-04 PET, with evaluation metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC). Correlation analyses will be performed between PET parameters and clinicopathological characteristics, including tumor markers, pathological subtype, and immunohistochemical markers.The study is expected to provide a novel molecular imaging tool to support early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day | Experimental | Diagnostic Test: FAPI-RuiJ, Diagnostic Test: FAPI-04Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-RuiJ administered first and FAPI-04 on a separate day (interval: 1-7 days). For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time. All images will be independently reviewed by two blinded nuclear medicine physicians. Histopathology or imaging follow-up serves as the reference standard. |
| Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day | Experimental | Diagnostic Test: FAPI-RuiJ, Diagnostic Test: FAPI-04Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-04 administered first and FAPI-RuiJ on a separate day (interval: 1-7 days). For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time. All images will be independently reviewed by two blinded nuclear medicine physicians. Histopathology or imaging follow-up serves as the reference standard. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 80 years, regardless of gender.
- Participants with suspected, confirmed, or suspected recurrent solid tumors.
- Participants who agree to participate in this clinical trial and provide written informed consent.
- Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process.
- No plans for pregnancy within 6 months.
Key exclusion criteria (5 listed)
- Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency.
- Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures.
- Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions.
- Pregnant or breastfeeding women.
- Patients with poor compliance.
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 |
|---|---|---|
| FAPI-RuiJA novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously. | Diagnostic test | Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day, Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day |
| FAPI-04A FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously. | Diagnostic test | Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day, Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day |
Primary outcome
Diagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET
Time frame: Through study completion, an average of 3 years
Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard.
AUC of FAPI-RuiJ PET versus FAPI-04 PET
Time frame: Through study completion, an average of 3 years
Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard.
4 secondary outcomes
Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Time frame: At the time of PET/CT scan
Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Time frame: At the time of PET/CT scan
Biodistribution characteristics of FAPI-RuiJ PET in normal organs
Time frame: At the time of PET/CT scan
Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors
Time frame: Through study completion, an average of 3 years
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 20 Aug 2026.
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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.
Biao Li principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI-RuiJ and FAPI-04 in people with Solid Tumor, run by Ruijin Hospital 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 5 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 20 Aug 2026. 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.
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 Ying Miao (0086-13671921521, myada821@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. 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 20 Aug 2026.