Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy (USA)
|ClinicalTrials.gov Identifier: NCT01227642|
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Clinical Stage T2b or Less of Prostate Cancer Prostate Brachytherapy Transrectal Prostate Ultrasound Treatment Planning||Other: An ultrasound-based technique to identify prostate cancer Other: pre-implant transrectal ultrasound images and planning Other: ultrasound-based cancer-specific images||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: pre-implant transrectal ultrasound images and planning
Transrectal ultrasound session will be performed at a separate session prior to the implant.
Other: An ultrasound-based technique to identify prostate cancer
The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.
Other: pre-implant transrectal ultrasound images and planning
an ultrasound-based technique to identify cancer-containing areas within the prostate.
Other: ultrasound-based cancer-specific images
ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning
Other Name: The ultrasound unit used is the B+K Hawk 2102 with probe #8658.
- modified B+K ultrasound-based tissue-type images [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227642
|United States, New York|
|St.Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10019|
|Principal Investigator:||Ronald Ennis, MD||St. Luke's-Roosevelt Hospital Center|