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68Ga-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer.
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-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-JH04.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dynamic PET scans | Experimental | PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-JH04 | Drug | The dose will be 148-222 MBq given intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | 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. | Up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Human biodistribution | reported as relative uptake values per organ at 3 minutes, 15 minutes, 30 minutes, 60 minutes and 150 minutes per individual subject and as a mean over all subjects | From right after tracer injection to 150 minutes at post-injection |
| Human dosimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Miao, MD | Contact | +86-0591-87981618 | miaoweibing@126.com | |
| Guochang Wang, PhD | Contact | +86-0591-87981619 | guochang1007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weibing Miao, MD | The First Affiliated Hospital, Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Drug: 68Ga-JH04
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radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects. Dosimetry will be calculated using the Hybrid-Dosimetry software. |
| From right after tracer injection to 150 minutes at post-injection |