68Ga-JH04 PET/CT in Patients With Various Types of Cancer
- Registration Number
- NCT06455735
- Brief Summary
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-JH04 is promising as an excellent imaging agent for various cancers. In this study, we observed the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
- 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, showing high efficacy in tumor staging and restaging. As an emerging molecule targeting FAP, 68Ga-JH04, in this study, the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer were observed. Its imaging results were compared with those of 68Ga-FAPI or 18F-FDG PET/CT.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
- PARALLEL
- Arm && Interventions
Group Intervention Description 68Ga-FAPI/18F-FDG PET/ CT 68Ga-FAPI/18F-FDG Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT. 68Ga-JH04 PET/ CT 68Ga-JH04 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-JH04. Tracer doses of 68Ga-JH04 will be used to detect tumors by PET/CT.
- Primary Outcome Measures
Name Time Method Diagnostic value through study completion, an average of 3 months Sensitivity and Specificity of 68Ga-JH04 in Patients With Various Types of Cancer and comrared it with 68Ga-FAPI/18F-FDG PET/CT.
- Secondary Outcome Measures
Name Time Method SUV of tumors through study completion, an average of 3 months Compare the SUV of tumors between 68Ga-JH04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China