Clinical trial · Interventional
Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
NCT07144085CI-TRIAL-00107298recruitingPhase 1ClinicalTrials.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)
A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and biodistribution after administration.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FXX489 | Drug | — | UNRESOLVED |
| Gallium-68 labelled (68Ga-) FAP-2286 | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor population
- description
- PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FXX489 or 68Ga-FAP-2286 or 18F-FDG.
- interventionNames
- Drug: 68Ga-FXX489
- Procedure: Positron Emission Tomography (PET) imaging
- Drug: Gallium-68 labelled (68Ga-) FAP-2286
Primary outcomes (5)
- measure
- Count of participants with treatment-emergent adverse events
- timeFrame
- Up to 3 days
- description
- The frequency and severity of treatment emergent adverse events following FXX489(NNS306) injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
- measure
- Proportion of radiation-absorbed doses of radiolabeled FAP-2286.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a high suspicion of oncological diseases. 2. Age: 18-80 years, no gender restriction, able to express themselves independently, and willing to participate in this study with a signed informed consent form. Exclusion Criteria: 1. Failure to sign the informed consent form. 2. Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively. 3. Severe cardiac dysfunction, cardiac function class III-IV. 4. Renal failure (serum creatinine level \> 1.2 mg/dl). 5. Allergy to alcohol. 6. Use of drugs within 1 week prior to the examination that can cause a disulfiram-like reaction with alcohol, such as penicillins, cephalosporins, or cefotetan. 7. Known pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.