NCT07144085 Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
| NCT ID | NCT07144085 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yi Tian |
| Condition | Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-09-11 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Xuena Li
STUDY DIRECTOR
Department of Nuclear Medicine, The First Hospital of China Medical University
Frequently Asked Questions
Who can join the NCT07144085 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07144085 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07144085 currently recruiting?
Yes, NCT07144085 is actively recruiting participants. Contact the research team at lixuenacmunm@163.com for enrollment information.
Where is the NCT07144085 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT07144085 clinical trial?
NCT07144085 is sponsored by Yi Tian. The principal investigator is Xuena Li at Department of Nuclear Medicine, The First Hospital of China Medical University. The trial plans to enroll 30 participants.