Actively Recruiting
Application of 68Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases
Led by Yi Tian · Updated on 2026-04-03
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new radiotracer called 68Ga-FXX489 (NNS309) for its ability to track fibroblast activation protein (FAP) and visualize tumor stroma in various cancers, including pancreatic, lung, breast, gastric, and colorectal cancers. This phase 1 study aims to explore the diagnostic value, safety, imaging features, and biodistribution of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, as well as to assess its ability to detect metastatic disease and compare it with another tracer, FAP-2286. Participants will receive an intravenous dose of 3 to 8 millicurie (mCi) of 68Ga-FXX489 or Gallium-68 labelled FAP-2286 before undergoing PET imaging. Imaging scans will be conducted approximately 30 to 45 minutes per session at multiple time points: 30, 60, and 120 minutes after injection. Some participants may have repeat PET scans after starting treatment to evaluate changes in radiotracer uptake. The study also includes a follow-up period of up to 3 days after injection to monitor adverse events. During the trial, participants will undergo PET/CT scans to assess tumor uptake, retention, and metastatic disease detection using standardized uptake values (SUVs) and tumor-to-background ratio (TBR). Researchers will monitor safety by recording any treatment-emergent adverse events during the 3-day follow-up. The study will also evaluate radiation absorbed doses to organs and the proportion of positive lesions detected. Total participation includes imaging and safety monitoring over several days after radiotracer administration.
CONDITIONS
Brief Title
Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a high suspicion of oncological diseases
- Age between 18 and 80 years
- No gender restriction
- Able to express themselves independently
- Willing to participate with a signed informed consent form
You will not qualify if you...
- Failure to sign the informed consent form
- Severe visual or auditory impairment, cognitive disorders, or claustrophobia preventing effective communication
- Severe cardiac dysfunction, cardiac function class III-IV
- Renal failure with serum creatinine level above 1.2 mg/dl
- Allergy to alcohol
- Use of drugs within 1 week prior to examination that can cause disulfiram-like reaction with alcohol (e.g., penicillins, cephalosporins, cefotetan)
- Known pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants receive an intravenous injection of a radiolabeled drug followed by PET/CT imaging to assess tumor uptake and detect metastatic disease.
1 to 3 imaging visits within 3 days after injection
Duration - Up to 3 days
Participants are monitored for up to 3 days after injection for safety and adverse events related to the imaging procedures.
Follow-up assessments during the 3 days after injection
Trial Site Locations
Total: 1 location
1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
X
Xuena Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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