An Early Phase 1 interventional study of Copper Cu 64 TP3805 and Positron Emission Tomography in Bladder Urothelial Carcinoma and Urothelial Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Early Phase 1, Interventional, and Diagnostic
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.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's enrollment of 20 is below the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Copper Cu 64 TP3805 · Procedure: Positron Emission Tomography · Procedure: Computed Tomography
Given IV
Also known as: Cu-64-TP3805
Undergo Cu-64-TP3805 Positron Emission Tomography scan
Also known as: Medical Imaging, PET, Positron Emission Tomography Scan
Undergo Cu-64-TP3805 Computed Tomography scan
Also known as: CAT, Computerized Axial Tomography, CAT scan
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
Time frame: Up to 4 weeks post-intervention
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.
Time frame: Up to 120 minutes post injection
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.
Time frame: Up to 120 minutes post injection
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University