Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-75 years old, any gender;
Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis;
Presence of at least 1 measurable lesion (RECIST 1.1 criteria);
ECOG score 0-2 and expected survival ≥ 12 weeks;
Disqualifiers
Major surgery or trauma within 4 weeks;
Severe infection, liver or kidney insufficiency;
History of allergies (developer components);
Pregnant/nursing female or not using effective contraception;
Trial design
Treatments tested in this trial
- 18F-FAPI-04 PET scan
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor
Weifang People's Hospital
Collaborator
Zibo Central Hospital
Collaborator
Qianfoshan Hospital
Collaborator
Jining Medical University
Collaborator
Source ClinicalTrials.gov