Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

This study aims to enroll 30 patients aged 18-75 years with clinically or pathologically confirmed breast cancer or suspected recurrence/metastasis, including both early-stage (I-II) and advanced-stage (III-IV) cases. The primary objective is to evaluate the diagnostic and therapeutic monitoring value of 18F-FAPI-04 PET for identifying primary tumors, metastatic lesions, and assessing treatment response. Exclusion criteria include: concurrent malignancies (except non-breast malignancies cured \>5 years prior), severe hepatic or renal dysfunction, and pregnancy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 18F-FAPI-04 PET scan

    Radiation

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 18F-FAPI-04 PET scan1 intervention

Trial outcomes

Primary outcomes

1

SUV

The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
Apply now