Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
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|ClinicalTrials.gov Identifier: NCT02989623|
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Copper Cu 64 TP3805 Procedure: Positron Emission Tomography and Computed Tomography Scan||Not Applicable|
I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA|
|Actual Study Start Date :||September 1, 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.
Radiation: Copper Cu 64 TP3805
Other Name: Cu-64-TP3805
Procedure: Positron Emission Tomography and Computed Tomography Scan
Undergo copper Cu 64 TP3805 PET/CT scan
- Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET [ Time Frame: Up to 3 years ]The proportion of lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.
- Incidence of multiple lesions in an individual patient [ Time Frame: Up to 3 years ]Generalized Estimating Equations will be utilized.
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): NCT02989623
|Contact: Madhukar Thakur, PhD||215-503-7874|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Madhukar Thakur, PhD 215-503-7874|
|Principal Investigator:||Madhukar Thakur, PhD||Thomas Jefferson University|