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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03039413
Other study ID # 16G.500
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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