Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
Condition: Bladder Urothelial Carcinoma, Urothelial Carcinoma
Intervention:
- Drug: Copper Cu 64 TP3805
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
Purpose: 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.
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03039413
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Primary Outcome Measures:
- Measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
- Time Frame: Up to 4 weeks post-intervention
- Safety Issue:
Secondary Outcome Measures:
- Measure: Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
- Time Frame: Up to 120 minutes post injection
- Safety Issue:
- Measure: Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
- Time Frame: Up to 120 minutes post injection
- Safety Issue:
Estimated Enrollment: 30
Study Start Date: September 28, 2016
Phase: Early Phase 1
Eligibility:
- Age: minimum 18 Years maximum 75 Years
- Gender: All
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
Contact:
- Madhukar Thakur, PhD
- madhukar.thakur@jefferson.edu
Location:
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Philadelphia Pennsylvania 19107 United States
View trial on ClinicalTrials.gov
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