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RECRUITING
NCT06916338

Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive/negative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Additionally, the study will longitudinally monitor dynamic changes in FAP expression levels and tumor size during therapy, including chemotherapy, targeted therapy, or immunotherapy.The non-invasive nature of 18F-FAPI-04 PET addresses limitations of traditional biopsy-dependent stromal evaluation, offering whole-body quantification of tumor microenvironment dynamics to optimize therapeutic decision-making.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-04-11

Completion Date

2027-12

Last Updated

2025-04-29

Healthy Volunteers

No

Conditions

Interventions

RADIATION

18F-FAPI-04 PET scan

FAPI-04, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-FAPI-04 PET scan.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China