Malignant Neoplasm
Conditions
Brief summary
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.
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-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.
Interventions
DRUG68Ga-JH04
The dose will be 148-222 MBq given intravenously.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Drug: 68Ga-JH04
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 |
|---|---|---|
| Human biodistribution | From right after tracer injection to 150 minutes at post-injection | 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 |
| Human dosimetry | From right after tracer injection to 150 minutes at post-injection | 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. |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactGuochang Wang, PhD
Outcome results
None listed