A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Blue Earth Diagnostics
Summary
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements. 2. Participants must be ≥ 18 years and \< 80 years of age and competent to give informed consent. 3. Eastern Cooperative Oncology Group performance status ≤ 2. 4. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology). 5. Women of childbearing potential (WOCBP) should have…
Interventions
- Drug[18F]FPyQCP
positron emission tomography (PET)/computed tomography (CT) imaging
Location
- University of Texas Southwestern Medical CenterDallas, Texas