Fusion Targeted Biopsy of the Prostate
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|ClinicalTrials.gov Identifier: NCT02013414|
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: 3D ultrasound-guided biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Image-directed, 3D Ultrasound-guided Biopsy of the Prostate|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 23, 2018|
|Actual Study Completion Date :||July 23, 2018|
Experimental: 3D ultrasound-guided biopsy
Participants will have a 3D ultrasound-guided biopsy of the prostate rather than the standard of care 2D ultrasound-guided biopsy.
Device: 3D ultrasound-guided biopsy
Patients will have a PET/CT prior to the biopsy. The CT images will be combined with the PET images for improved localization of suspicious tumors. During the biopsy, the 3-D ultrasound images will be acquired immediately before the biopsy while the patient is on the table. The ultrasound images together with the PET images will be used to guide the targeted biopsy of the prostate.
- Cancer Detection by Targeted and Standard Biopsy Approaches [ Time Frame: Up to 2 years ]The feasibility of detecting cancer detection with the targeted prostate biopsy was assessed. This study sought only to determine if the targeted biopsy approach was able to detect recurrent prostate cancer and values for the number of samples testing positive for cancer per each biopsy approach are not available. This feasibility study preceded a clinical trial (NCT02744534) assessing the accuracy of prostate cancer detection with targeted biopsies compared to the standard biopsy.
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): NCT02013414
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Baowei Fei, PhD, EngD||Emory University|