Clinical trial · Interventional
Clinical Applications of FAPI PET in Solid Tumors
Clinical Applications of Novel FAPI PET in Diverse Solid Tumors
NCT07776899CI-TRIAL-00122981recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAPI-04 | Diagnostic Test | — | UNRESOLVED |
| FAPI-RuiJ | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day
- description
- 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.
- interventionNames
- Diagnostic Test: FAPI-RuiJ
- Diagnostic Test: FAPI-04
- type
- EXPERIMENTAL
- label
- Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.