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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Urothelial Carcinoma, Urothelial Carcinoma

Intervention / Treatment
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* Drug: Copper Cu 64 TP3805
* Procedure: Positron Emission Tomography
* Procedure: Computed Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (Copper Cu 64 TP3805 PET/CT)<br>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. | Drug: Copper Cu 64 TP3805<br>* Given IV<br>* Other names: Cu-64-TP3805;Procedure: Positron Emission Tomography<br>* Undergo Cu-64-TP3805 Positron Emission Tomography scan<br>* Other names: Positron Emission Tomography Scan;Procedure: Computed Tomography<br>* Undergo Cu-64-TP3805 Computed Tomography scan<br>* Other names: CAT scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology | 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 | Up to 4 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value | The blood clearance time from all subjects shall be averaged with standard error of the mean. | Up to 120 minutes post injection | 
| Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples | Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined. | Up to 120 minutes post injection |