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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Early Phase 1

Conditions: Urothelial Carcinoma; Bladder Urothelial Carcinoma

Treatments: Procedure: Positron Emission Tomography; Drug: Copper Cu 64 TP3805; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT03039413

JT 9148 (Other Identifier)

16G.500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Diagnostic (Copper Cu 64 TP3805 PET/CT)

Experimental group

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.

Treatment:

Procedure: Computed Tomography

Drug: Copper Cu 64 TP3805

Procedure: Positron Emission Tomography