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

NCT06916338 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-29

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Weifang People's Hospital

    collaborator OTHER

  • Zibo Central Hospital

    collaborator OTHER_GOV

  • Qianfoshan Hospital

    collaborator OTHER

  • Jining Medical University

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916338 on ClinicalTrials.gov