Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in China / NCT06916338
Recruiting Observational

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

NCT06916338 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital of Qingdao University
Phase
Observational
Started
2025-04-11
Last updated
2025-04-29

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

18F-FAPI-04 PET scan

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • SUV — 2 years
    The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET

Trial sites (1)

FacilityCityRegionStatus
The Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting

More The Affiliated Hospital of Qingdao University trials in China

Safety and Efficacy of Small Extracellular Vesicles Nebulizer in Patients With Allergic Rhinitis Complicated With Asthma Starting soon
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy Starting soon
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas Recruiting
Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer Starting soon
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01） Recruiting

Other trials for the same condition

Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer Recruiting
Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy Recruiting
A Study on Predicting the Risk of Distant Metastasis in Breast Cancer Using AI-Generated Spatial Pathological Maps Recruiting
Research on the Development and Validation of Personalized Exercise Prescription System for Breast Cancer Patients Based on Large Language Models Starting soon
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06916338 on ClinicalTrials.gov ↗ ← All trials in China