drugset / Trial / NCT03790423

18F-ASIS PET/CT Imaging of Tissue Factor Expression In Patients With Primary and Metastastic Cancer

NCT03790423 ↗

Phase 1 Completed 10 enrolled Rigshospitalet, Denmark
NaSingle-groupOpen-labelDiagnostic

Summary

The primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging of tissue factor (TF) expression. The tracer has the potential of identifying tumors with high levels of TF expression, which is expected to correlate with tumor aggression and prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic agent for identifying patients eligible for TF directed therapies. This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and 4 hours post-injection).

Timeline

Start
2019-01-03
Primary completion
2019-11-18
Completion
2019-11-18

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-ASIS Diagnostic / imaging agent 200 mbq Other