NCT06943313

Breast Cancer PET/CT Imaging With 68Ga-pAKTi

68Ga-Labeled pAKTi Molecular Probe Combined With PET/CT for Breast Cancer Imaging

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation. In this study, we utilize a novel probe, 68Ga-pAKTi, which enables precise targeting of tumor p-AKT expression levels to monitor PI3K-AKT pathway activation. The aim of this study is to evaluate the diagnostic accuracy of 68Ga-pAKTi PET/CT in detecting p-AKT expression in breast cancer and to compare its performance with that of 18F-FDG PET/CT. A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging. Biopsy/pathological results and conventional imaging findings will be followed up to validate the diagnostic efficacy of 68Ga-pAKTi PET/CT in accurately detecting p-AKT expression in breast cancer.

Conditions

• Breast Cancers
• PIK3CA Mutation-Related Tumors
• PI3K Pathway Activated Tumors
• PET / CT

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-pAKTi PET/CT probe	A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging.

Timeline

• Start date: 2025-04-21
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: China