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

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

Condition: Bladder Urothelial Carcinoma, Urothelial Carcinoma

Intervention:

  • Drug: Copper Cu 64 TP3805
  • Procedure: Positron Emission Tomography
  • Procedure: Computed Tomography

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03039413

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Primary Outcome Measures:

  • Measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
  • Time Frame: Up to 4 weeks post-intervention
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
  • Time Frame: Up to 120 minutes post injection
  • Safety Issue:
  • Measure: Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
  • Time Frame: Up to 120 minutes post injection
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: September 28, 2016

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

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

Contact:

  • Madhukar Thakur, PhD
  • madhukar.thakur@jefferson.edu

Location:

  • Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Philadelphia Pennsylvania 19107 United States

View trial on ClinicalTrials.gov

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