68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study
- Registration Number
- NCT06688188
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5
- Various solid tumors with available histopathological findings
- Signed informed consent
- pregnant or lactational women
- who suffered from severe hepatic and renal insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dynamic PET scans 68Ga-JH12 PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China