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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03039413
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
64.1
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Copper Cu 64 TP3805
  • Procedure: Positron Emission Tomography
  • Procedure: Computed Tomography
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.
SECONDARY OBJECTIVES:
  1. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.
TERTIARY:
  1. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
Actual Study Start Date :
Sep 28, 2016
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (Copper Cu 64 TP3805 PET/CT)

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.

Drug: Copper Cu 64 TP3805
Given IV
Other Names:
  • Cu-64-TP3805

    • Procedure: Positron Emission Tomography
    Undergo Cu-64-TP3805 Positron Emission Tomography scan
    Other Names:
  • Medical Imaging
  • PET
  • Positron Emission Tomography Scan

    • Procedure: Computed Tomography
    Undergo Cu-64-TP3805 Computed Tomography scan
    Other Names:
  • CAT
  • Computerized Axial Tomography
  • CAT scan

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03039413
    Other Study ID Numbers:
    • 16G.500
    First Posted:
    Feb 1, 2017
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Transitional Cell
    Copper

    Study Results

    No Results Posted as of Sep 1, 2021