First Affiliated Hospital of Fujian Medical University
Phase
Phase EARLY_PHASE1
Started
2024-08-01
Last updated
2024-11-14
Condition(s) studied
Malignant Neoplasm
Investigational drug(s) / intervention(s)
68Ga-NI-FAPI
68Ga-NI-FAPI: Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.
Study summary
68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Various solid tumors with available histopathological findings
* Signed informed consent
Exclusion Criteria:
* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency
Primary outcome measure(s)
safety and tolerability — up to 1 week Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Trial sites (1)
Facility
City
Region
Status
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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