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Trial record 2 of 18 for:    cu-64

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

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ClinicalTrials.gov Identifier: NCT03039413
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Bladder Urothelial Carcinoma Urothelial Carcinoma Drug: Copper Cu 64 TP3805 Procedure: Positron Emission Tomography Procedure: Computed Tomography Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : September 28, 2016
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


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 Name: 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




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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039413


Contacts
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Contact: Madhukar Thakur, PhD madhukar.thakur@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Madhukar Thakur, PhD       madhukar.Thakur@jefferson.edu   
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Madhukar Thakur, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03039413     History of Changes
Other Study ID Numbers: 16G.500
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs