Clinical trial · Observational
Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FAPI-04 PET scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 18F-FAPI-04 PET scan
- interventionNames
- Radiation: 18F-FAPI-04 PET scan
Primary outcomes (1)
- measure
- SUV
- timeFrame
- 2 years
- description
- The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, any gender; 2. Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis; 3. Presence of at least 1 measurable lesion (RECIST 1.1 criteria); 4. ECOG score 0-2 and expected survival ≥ 12 weeks; 5. Laboratory markers are met: Blood count: WBC ≥4.0×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L Liver and kidney function: ALT/AST ≤ 2.5 × ULN, SCr ≤ 1.5 × ULN; 6. Signed informed consent. Exclusion Criteria: 1. Major surgery or trauma within 4 weeks; 2. Severe infection, liver or kidney insufficiency; 3. History of allergies (developer components); 4. Pregnant/nursing female or not using effective contraception; 5. Inability to co-operate with PET (e.g. claustrophobia); 6. Any other situation that researchers considered it unsuitable to participate in the trial.
References
Publications (0)
Data not yet available