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.
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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | September 28, 2016 | Early Phase 1 | Interventional |
Primary Outcome 1 - Measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
Primary Outcome 1 - Time Frame: Up to 4 weeks post-intervention
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
<br/> - 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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Gender: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Healthy Volunteers: No
Name: Madhukar Thakur, PhD
Role: Principal Investigator
Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
Name: Madhukar Thakur, PhD
Phone:
Email: madhukar.thakur@jefferson.edu
Link: Sidney Kimmel Cancer Center
| Facility | Status | Contact |
|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia, Pennsylvania 19107 United States |
Recruiting |
Madhukar Thakur, PhD madhukar.Thakur@jefferson.edu |
