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

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

INTRODUCTION

  • Org Study ID: 16G.500
  • Secondary ID: N/A
  • NTC ID: NCT03039413
  • Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.


  • Overall Status
    Recruiting
  • Start Date
    September 28, 2016
  • Phase
    Early Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology

Primary Outcome 1 - Timeframe: Up to 4 weeks post-intervention

CONDITION

  • Bladder Urothelial Carcinoma
  • Urothelial Carcinoma

ELIGIBILITY


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

Minimum Age: 75 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Madhukar Thakur, PhD

Role: Principal Investigator

Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University

Overall Contact

Name: Madhukar Thakur, PhD

Phone: N/A

Email: madhukar.thakur@jefferson.edu

LOCATION

Facility Status Contact
Facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States 		Status: Recruiting Contact:
Madhukar Thakur, PhD

madhukar.Thakur@jefferson.edu

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