68Ga-FXX489 PET/CT to image tumor stroma and metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: Xuena Li
• Email: lixuenacmunm@163.com
• Phone: 0086-18040099351

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.