FAPI PET imaging with FAPI-RuiJ and FAPI-04 in solid tumors
Official title: Clinical Applications of Novel FAPI PET in Diverse Solid Tumors
Run by Ruijin Hospital · NCT07776899 · Data updated 2026-11-12
This study tests two FAP-targeted PET tracers (FAPI-RuiJ and FAPI-04) to see which better detects, stages, and monitors solid tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | July 2, 2026 |
| Main results expected | March 31, 2029 |
| Study ends | March 31, 2029 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07776899 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with suspected, confirmed, or recurrent solid tumors who can tolerate paired PET imaging and provide informed consent.
✕Probably not a fit
Patients with non-solid tumors or those unable to complete both imaging sessions may receive limited or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study compares the imaging performance of two fibroblast activation protein–targeted tracers, FAPI-RuiJ and FAPI-04, across a range of solid tumors. Each participant undergoes paired PET imaging with both tracers, with measurements of uptake values and distribution in normal tissues. Diagnostic performance will be assessed against histopathology or follow-up imaging, using metrics such as sensitivity, specificity, PPV, NPV, accuracy, and AUC. Correlations between PET parameters and clinicopathological features will also be explored. The aim is to determine whether FAPI-RuiJ offers advantages for early lesion detection, staging, and recurrence surveillance compared with FAPI-04.
Why it matters
Potential benefit: If successful, patients may benefit from improved PET imaging that better detects and monitors solid tumors.
How similar studies have gone: Previous studies with FAPI tracers have shown promise, but direct head-to-head comparisons like this are less common and represent a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 80 years, regardless of gender. 2. Participants with suspected, confirmed, or suspected recurrent solid tumors. 3. Participants who agree to participate in this clinical trial and provide written informed consent. 4. Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process. 5. No plans for pregnancy within 6 months. Exclusion Criteria: 1. 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. 2. Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures. 3. Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions. 4. Pregnant or breastfeeding women. 5. Patients with poor compliance.
Where it's running
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China Recruiting
Study contacts
- Principal investigator: Biao Li — Ruijin Hospital
- Study coordinator: Ying Miao
- Email: myada821@hotmail.com
- Phone: 0086-13671921521
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.