NCT03039413

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

Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology. SECONDARY OBJECTIVES: I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805. TERTIARY: I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.

Conditions

• Bladder Urothelial Carcinoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Copper Cu 64 TP3805	Given IV
PROCEDURE	Positron Emission Tomography	Undergo Cu-64-TP3805 Positron Emission Tomography scan
PROCEDURE	Computed Tomography	Undergo Cu-64-TP3805 Computed Tomography scan

Timeline

• Start date: 2016-09-28
• Primary completion: 2019-05-21
• Completion: 2024-07-19
• First posted: 2017-02-01
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study