Malignant Neoplasm
Conditions
Brief summary
68Ga-JH12 is a novel radiotracer targeting C-X-C motif chemokine receptor 4 (CXCR4). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with different types of cancer.
Detailed description
C-X-C motif chemokine receptor 4 (CXCR4) is highly expressed in patients affected with malignant tumors and ex-vivo analyses provided evidence that the expression level on the tumor cell surface is tightly linked to the proliferation index. In recent years, the diagnostic PET agent 68Ga-Pentixafor targeting this chemokine receptor has been extensively validated in haematological malignancies and solid tumors. 68Ga-JH12, a novel radiopharmaceutical targeting CXCR4, 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-JH12 in patients with Various Cancers were observed to evaluate the dosimetric characteristics of 68Ga-JH12.
Interventions
DRUG68Ga-JH12
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
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-JH12. The dose delivered to normal organs and tumors will be recorded. |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactGuochang Wang, MD
Outcome results
None listed