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| ID | Type | Description | Link |
|---|---|---|---|
| JT 9148 | Other Identifier | JeffTrial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (Copper Cu 64 TP3805 PET/CT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper Cu 64 TP3805 | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 120 minutes post injection |
| Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhukar Thakur, PhD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| Positron Emission Tomography | Procedure | Undergo Cu-64-TP3805 Positron Emission Tomography scan |
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| Computed Tomography | Procedure | Undergo Cu-64-TP3805 Computed Tomography scan |
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Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined. |
| Up to 120 minutes post injection |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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