Malignant Neoplasm
Conditions
Brief 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.
Detailed description
Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.
Interventions
DRUG68Ga-NI-FAPI
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry of normal organs and tumors | From right after tracer injection to 150 minutes at post-injection | The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 68Ga-NI-FAPI. The dose delivered to normal organs and tumors will be recorded. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value | through study completion, an average of 3 months | Sensitivity and Specificity of 68Ga-NI-FAPI for patients with various cancers. |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactJie Zang, MD
Outcome results
None listed