Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
- Conditions
- Urothelial CarcinomaBladder Urothelial Carcinoma
- Interventions
- Registration Number
- NCT03039413
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (Copper Cu 64 TP3805 PET/CT) Copper Cu 64 TP3805 Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later. Diagnostic (Copper Cu 64 TP3805 PET/CT) Positron Emission Tomography Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later. Diagnostic (Copper Cu 64 TP3805 PET/CT) Computed Tomography Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.
- Primary Outcome Measures
Name Time Method Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology Up to 4 weeks post-intervention For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology
- Secondary Outcome Measures
Name Time Method Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples Up to 120 minutes post injection Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.
Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value Up to 120 minutes post injection The blood clearance time from all subjects shall be averaged with standard error of the mean.
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States