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

Primary Purpose

Bladder Urothelial Carcinoma, Urothelial Carcinoma

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Copper Cu 64 TP3805
Positron Emission Tomography
Computed Tomography
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Urothelial Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Copper Cu 64 TP3805 PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
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

Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
The blood clearance time from all subjects shall be averaged with standard error of the mean.
Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.

Full Information

First Posted
January 31, 2017
Last Updated
June 2, 2023
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03039413
Brief Title
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
Official Title
Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
January 2023 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Urothelial Carcinoma, Urothelial Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (Copper Cu 64 TP3805 PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Copper Cu 64 TP3805
Other Intervention Name(s)
Cu-64-TP3805
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, PET, Positron Emission Tomography Scan
Intervention Description
Undergo Cu-64-TP3805 Positron Emission Tomography scan
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, Computerized Axial Tomography, CAT scan
Intervention Description
Undergo Cu-64-TP3805 Computed Tomography scan
Primary Outcome Measure Information:
Title
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
Description
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
Time Frame
Up to 4 weeks post-intervention
Secondary Outcome Measure Information:
Title
Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
Description
The blood clearance time from all subjects shall be averaged with standard error of the mean.
Time Frame
Up to 120 minutes post injection
Title
Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
Description
Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.
Time Frame
Up to 120 minutes post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar Thakur, PhD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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