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

Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03039413
• Other study ID #: 16G.500
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 28, 2016
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Urothelial Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Copper Cu 64 TP3805
Given IV

Procedure:
• Positron Emission Tomography
Undergo Cu-64-TP3805 Positron Emission Tomography scan
• Computed Tomography
Undergo Cu-64-TP3805 Computed Tomography scan

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 4 weeks post-intervention
Secondary	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.	Up to 120 minutes post injection
Secondary	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.	Up to 120 minutes post injection

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital