Actively Recruiting
68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-11-14
5
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying 68Ga-JH12, a new radiotracer that targets the CXCR4 receptor, which is commonly found in various malignant tumors. This early phase 1 trial aims to assess the safety, distribution in the body, and radiation dose of 68Ga-JH12 in patients with different types of cancer. Previous studies showed that CXCR4 levels are linked to tumor growth, and 68Ga-JH12 has demonstrated stability and selective tumor accumulation in preclinical tests. Participants will receive an intravenous dose of 68Ga-JH12 ranging from 148 to 222 MBq. Dynamic PET scans will be performed at multiple time points after injection—starting at 3 minutes and continuing through 150 minutes—to observe how the tracer travels and accumulates in normal organs and tumors. This imaging process helps evaluate the tracer’s dosimetric properties. During the study, participants will be monitored for safety and tolerability for up to one week following tracer administration. Researchers will collect data on how the tracer distributes and the radiation it delivers to normal tissues and tumors. This study is expected to continue until the end of 2025, and participants will undergo scheduled PET imaging and safety assessments as part of their involvement.
CONDITIONS
Brief Title
68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Various solid tumors with available histopathological findings
- Signed informed consent
You will not qualify if you...
- Pregnant or lactational women
- Severe hepatic and renal insufficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 hours on the day of injection
Participants receive an intravenous injection of the 68Ga-JH12 tracer followed by multiple PET scans to assess safety, biodistribution, and radiation dosimetry.
1 visit (in-person) with PET scans at 3, 15, 30, 60, and 150 minutes post-injection
Duration - Up to 1 week
Participants are monitored for safety and tolerability after the tracer injection.
Follow-up contact or visit within 1 week after injection
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, MD
G
Guochang Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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