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

Early Phase 1CompletedNCT03039413

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Bladder Urothelial Carcinoma Urothelial Carcinoma

Interventions

Copper Cu 64 TP3805DRUG

Given IV

Positron Emission TomographyPROCEDURE

Undergo Cu-64-TP3805 Positron Emission Tomography scan

Computed TomographyPROCEDURE

Undergo Cu-64-TP3805 Computed Tomography scan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 4 weeks post-intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 120 minutes post injection

Data from ClinicalTrials.gov

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