Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
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|ClinicalTrials.gov Identifier: NCT03039413|
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bladder Urothelial Carcinoma Urothelial Carcinoma||Drug: Copper Cu 64 TP3805 Procedure: Positron Emission Tomography Procedure: Computed Tomography||Early Phase 1|
I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.
I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.
I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation|
|Actual Study Start Date :||September 28, 2016|
|Estimated Primary Completion Date :||March 15, 2021|
|Estimated Study Completion Date :||January 30, 2022|
Experimental: Diagnostic (Copper Cu 64 TP3805 PET/CT)
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
Other Name: Cu-64-TP3805
Procedure: Positron Emission Tomography
Undergo Cu-64-TP3805 Positron Emission Tomography scan
Procedure: Computed Tomography
Undergo Cu-64-TP3805 Computed Tomography scan
- Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology [ Time Frame: Up to 4 weeks post-intervention ]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
- Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value [ Time Frame: Up to 120 minutes post injection ]The blood clearance time from all subjects shall be averaged with standard error of the mean.
- Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples [ Time Frame: Up to 120 minutes post injection ]Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039413
|Contact: Madhukar Thakur, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Madhukar Thakur, PhD madhukar.Thakur@jefferson.edu|
|Principal Investigator:||Madhukar Thakur, PhD||Sidney Kimmel Cancer Center at Thomas Jefferson University|