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Completed

NCT Number: NCT03039413

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

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.

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Key information

Conditions

Bladder Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Urothelial Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper Cu 64 TP3805

Drug

Given IV

Other names: Cu-64-TP3805

Positron Emission Tomography

Procedure

Undergo Cu-64-TP3805 Positron Emission Tomography scan

Other names: Medical Imaging, PET, Positron Emission Tomography Scan

Computed Tomography

Procedure

Undergo Cu-64-TP3805 Computed Tomography scan

Other names: CAT, Computerized Axial Tomography, CAT scan

Primary outcomes

  1. Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology

    Time frame: 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 outcomes

  1. Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value

    Time frame: Up to 120 minutes post injection

    The blood clearance time from all subjects shall be averaged with standard error of the mean.

  2. Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2024
First posted
Feb 1, 2017
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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