Urothelial Carcinoma Clinical Trial
Official title:
Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
Verified date | June 2023 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | April 2024 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | Up to 120 minutes post injection |
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