NCT06519760

68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma

Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1. Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Detailed description

Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Conditions

• Carbonic Anhydrase IX
• PET-CT
• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	68Ga-C1	68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg

Timeline

• Start date: 2024-07-30
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-07-25
• Last updated: 2024-11-07

Locations

1 site across 1 country: China