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As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
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, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTA-NI-FAPI04 PET/ CT | Experimental | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT. |
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| 68Ga-FAPI/18F-FDG PET/ CT | Experimental | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTA-NI-FAPI04 | Drug | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value | Sensitivity and Specificity of 68Ga-DOTA-NI-FAPI04 in Patients With Various Types of Cancer and comrare it with 68Ga-FAPI/18F-FDG PET/CT. | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| SUV of tumors | Compare the SUV of tumors between 68Ga-DOTA-NI-FAPI04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT. | through study completion, an average of 3 months |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Miao, MD | Contact | +86-0591-87981618 | miaoweibing@126.com | |
| Guochang Wang, MD | Contact | +86-0591-87981619 | guochang1007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weibing Weibing, MD | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 68Ga-FAPI/18F-FDG | Drug | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT. |
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