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

June 2, 2023 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • PET
  • Positron Emission Tomography Scan
  • Medical Imaging
Procedure: Computed Tomography
Undergo Cu-64-TP3805 Computed Tomography scan
Other Names:
  • CAT
  • Computerized Axial Tomography
  • CAT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 4 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 120 minutes post injection
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.
Up to 120 minutes post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

January 1, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimated)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16G.500

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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