Bladder Cancer Clinical Trial
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
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.
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.
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
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There is 1 Location for this study
Philadelphia Pennsylvania, 19107, United States
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