68Ga-FXX489 PET/CT to image tumor stroma and metastases
Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
This test will try a new PET/CT radiotracer called 68Ga-FXX489 in adults with suspected or confirmed solid tumors to see if it safely lights up tumors and metastatic disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07144085 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study will administer the 68Ga-labeled tracer FXX489 (NNS309) and perform PET/CT imaging to characterize safety, biodistribution, and organ dosimetry. Investigators will image a range of solid tumors initially focusing on pancreatic, lung, breast, gastric, and colorectal cancers and may repeat imaging after treatment to assess changes. The protocol includes short-term follow-up for adverse events for up to three days after injection and compares image quality across administered doses and versus an existing FAP agent (FAP-2286). The primary aims are to document tracer uptake and retention in tumors and to detect metastatic disease while confirming tolerability.
Who should consider this trial
Good fit: Adults 18–80 with suspected or confirmed solid tumors who can provide informed consent and tolerate PET/CT imaging are potential candidates.
Not a fit: Patients who are pregnant, have severe cardiac dysfunction, significant renal failure, or cannot tolerate imaging procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the tracer could help doctors detect and map primary tumors and metastases more clearly, potentially improving imaging-guided decisions.
How similar studies have performed: Other FAP-targeted PET tracers, including FAP-2286 and FAPI agents, have shown promising tumor uptake across multiple cancers, so this approach builds on prior positive imaging work.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenyang, Liaoning
- The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xuena Li
- Email: lixuenacmunm@163.com
- Phone: 0086-18040099351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.