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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
  • NCT 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
    Active, not recruiting
  • Start Date
    September 28, 2016
  • Phase
    E
  • 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

  • B
  • U

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: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: M

Role: P

Affiliation: S

Overall Contact

Name: M

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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