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

Detailed criteria

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 Center
Dallas, Texas

A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions