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

Brief Title

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

Official Title

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

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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Bladder Urothelial Carcinoma

Intervention

Copper Cu 64 TP3805

Study Arms / Comparison Groups

 Diagnostic (Copper Cu 64 TP3805 PET/CT)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 28, 2016

Completion Date

January 2023

Primary Completion Date

January 2023

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Madhukar Thakur, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03039413

Organization ID

16G.500

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Sponsor

Madhukar Thakur, PhD, Principal Investigator, Sidney Kimmel Cancer Center at Thomas Jefferson University

Verification Date

December 2022