Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy

• Status: Active, not recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

Summary

This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.

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

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Treatments: Copper

Criteria

Inclusion Criteria:

• Provide signed and dated informed consent form

• Willing to comply with all study procedures and be available for the duration of the study

• Must have diagnosis of urothelial cancer

• Scheduled for extirpative surgery or biopsy of suspected metastatic lesion

• Women of reproductive potential must have a urine pregnancy test day of injection

• Men of reproductive potential must use condoms

Exclusion Criteria:

• Pregnancy or lactation

• Known allergic reactions to components of the study product(s)

• Treatment with another investigational drug or other intervention with 24 hours of injection

• Must not have had an injection of a radioisotope 24 hours prior to exam