NCT07046702

68Ga-MY6349 PET/CT in Solid Tumors

68Ga-MY6349 PET/CT in Solid Tumors and Compared With 18F-FDG PET/CT

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to construct a noninvasive approach 68Ga-MY6349 PET/CT to detect the Trop-2 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from Trop-2 PET/CT.

Detailed description

As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-MY6349 is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with various types of tumors underwent contemporaneous 68Ga-MY6349 and standard-of-care imaging (18F-FDG) either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-MY6349 PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-MY6349 was calculated and compared to standard-of-care imaging.

Conditions

• Solid Tumor
• Trop2
• PET/CT

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-MY6349	Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-01
• Last updated: 2025-07-15

Locations

1 site across 1 country: China