Actively Recruiting
68Ga-JH04 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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, biodistribution, and radiation dosimetry of 68Ga-JH04, a new radiotracer targeting fibroblast activation protein (FAP), in patients with various types of cancer. FAP is a marker found on carcinoma-associated fibroblasts, which are common in many epithelial tumors but rare in normal tissues, making it a promising target for cancer diagnostics. This early phase 1 study aims to evaluate how 68Ga-JH04 behaves inside the body and its safety profile in cancer patients. Participants will receive an intravenous dose of 68Ga-JH04 ranging from 148 to 222 MBq. After injection, dynamic PET scans will be performed at multiple time points: 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 150 minutes. These imaging sessions will help observe how the tracer distributes and accumulates in tumors and other tissues over time. During the study, participants will undergo PET/CT imaging and safety monitoring for up to one week to track any side effects or adverse reactions. Researchers will measure radiation dosimetry and biodistribution based on imaging data collected shortly after injection and up to 150 minutes later. The total duration of participation and detailed assessments are designed to ensure thorough evaluation of the tracer's behavior and tolerability.
CONDITIONS
Brief Title
68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies
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.
1 visit (in-person)
Duration - Approximately 3 hours on the day of injection
Participants receive an intravenous injection of 68Ga-JH04 and undergo dynamic PET scans to evaluate biodistribution and dosimetry.
1 visit with multiple PET scans at 3, 15, 30, 60, and 150 minutes post-injection
Duration - Up to 1 week
Participants are monitored for safety and tolerability following the tracer injection.
Follow-up via 1 visit or contact to assess safety
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, PhD
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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