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
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
Secondary Outcome
Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
Condition
Bladder Urothelial Carcinoma
Intervention
Copper Cu 64 TP3805
Study Arms / Comparison Groups
Diagnostic (Copper Cu 64 TP3805 PET/CT)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
September 28, 2016
Completion Date
January 2023
Primary Completion Date
January 2023
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Madhukar Thakur, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03039413
Organization ID
16G.500
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Sponsor
Madhukar Thakur, PhD, Principal Investigator, Sidney Kimmel Cancer Center at Thomas Jefferson University
Verification Date
December 2022