Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/30/2018 |
| Start Date: | September 28, 2016 |
| End Date: | January 30, 2022 |
| Contact: | Madhukar Thakur, PhD |
| Email: | madhukar.thakur@jefferson.edu |
Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
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.
(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.
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.
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
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