Bladder Urothelial Carcinoma, Urothelial Carcinoma
Conditions
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.
Interventions
Given IV
PROCEDUREPositron Emission Tomography
Undergo Cu-64-TP3805 Positron Emission Tomography scan
PROCEDUREComputed Tomography
Undergo Cu-64-TP3805 Computed Tomography scan
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed