Trials / Recruiting
RecruitingNCT06455735
68Ga-JH04 PET/CT in Patients With Various Types of Cancer
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- First Affiliated Hospital of Fujian Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2025-12-01
- Completion
- 2026-04-01
- First posted
- 2024-06-12
- Last updated
- 2024-06-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06455735. Inclusion in this directory is not an endorsement.