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

• Status: Completed
• Trial end date: 2019-11-18
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Thromboplastin

Criteria

Inclusion Criteria:

• Diagnosed with breast, lung, pancreatic, cervix or ovarian cancer

• Capable of understanding the patient information in Danish and giving full informed consent

Exclusion Criteria:

• Pregnancy

• Breast-feeding

• Weight above 140 kg

• History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-ASIS