NCT05879471

68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma

68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.

Detailed description

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of 68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent, blinded interpretations. Imaging interpretations and a composite reference standard will be used to estimate the sensitivity of each modality. The tumor uptake will also be compared for matched lesions. 39 patients will be recruited in Peking Union Medical College Hospital.

Conditions

• Metastatic Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-NY104 PET/CT	Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-05-30
• Last updated: 2023-07-24

Locations

1 site across 1 country: China