First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia.
Jie Zang, Hongfei Cheng, Yang Luo...
https://pubmed.ncbi.nlm.nih.gov/41168395Actively Recruiting
Early Phase 1
Age: 18Years - 80Years
All Genders
ID06688305
68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-11-14
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging agent called 68Ga-NI-FAPI, which combines a hypoxia-sensitive nitroimidazole component with targeting of fibroblast activation protein (FAP). FAP is found in most epithelial cancer-associated fibroblasts but rarely in normal tissues, making it a promising target for cancer detection. This early-phase study aims to assess the safety, distribution, radiation dose, and diagnostic usefulness of 68Ga-NI-FAPI PET/CT scans in patients with various malignant tumors. Participants will receive a single intravenous injection of 68Ga-NI-FAPI at a dose of 111-148 MBq (3-4 mCi). After the injection, patients undergo PET/CT imaging to visualize tumor locations and characteristics. This procedure is designed to provide detailed information about tumor presence and behavior by targeting the tumor microenvironment. The study includes only one treatment group, and the imaging is done once following the tracer administration. During the study, participants will be monitored for safety and tolerability for up to one week after the injection. Researchers will also measure the radiation exposure to normal organs and tumors from the time of injection up to 150 minutes post-injection. The total involvement includes the injection, imaging, and follow-up monitoring to evaluate how the tracer behaves in the body and its potential for cancer diagnosis.
CONDITIONS
Brief Title
68Ga-NI-FAPI PET/CT: First-in-human Study
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Various solid tumors with available histopathological findings
- Signed informed consent
You will not qualify if you...
- Pregnant or lactational women
- Patients with severe hepatic and renal insufficiency
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Approximately 3 hours on the day of imaging
Participants receive an intravenous injection of 68Ga-NI-FAPI followed by PET/CT imaging to evaluate tumor presence and characteristics.
1 visit (in-person)
Follow-up
Duration - Up to 1 week
Participants are monitored for safety and tolerability following the imaging procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
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Research Team
W
Weibing Miao, MD
J
Jie Zang, MD
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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