Conventional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01401972|
Recruitment Status : Recruiting
First Posted : July 26, 2011
Last Update Posted : May 3, 2017
|Condition or disease|
This project is an early validation study in human subjects that will use ultrasound imaging and spectroscopy to predict the tumour extent before treatment so that this may allow the most appropriate treatment intervention to be individualised to patients. For examples, patients with evidence of extra-prostatic tissue involvement may be best served with definitive radiation therapy rather than radical prostatectomy as surgery alone in this situation, is not optimum. Furthermore, these ultrasound parameters may be used to monitor cell death occurring at various time points during patients' radiation treatment for prostate cancer.
The research is exploratory since upon data analysis it will examine the use of different ultrasound parameters as potential markers of pre-treatment tumour extent and cell death, and correlate these with tumour shrinkage and complete pathological response. Sensitivity and specificity values for the various ultrasound parameters will be calculated for the different time points used and receiver-operator curves will be generated. From this data the investigators will potentially estimate the best time-points at which to make a prediction about patient response and the best ultrasound-spectroscopy variables to use for this purpose.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
- ultrasound backscatter parameters such as aggregate mid-band fit, spectroscopic slope and intercept and the number of vessels with detectable blood flow and their sizes [ Time Frame: Up to year 2019 ]These parameters will be obtained before radical prostatectomy to correlate with pathological findings from the prostate specimen after surgery.
- sensitivity and specificity of ultrasound-based imaging of the prostate [ Time Frame: Up to year 2019 ]the changes in the ultrasound backscatter parameters obtained from the ultrasonic spectroscopy during patient's radiation treatment would be used to monitor tumor response and to correlate with pathological findings in patients with prostate cancer.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401972
|Contact: Gregory J. Czarnota||(416) 480-6100 ext email@example.com|
|Contact: William T. Tran||(416) 480-6100 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Gregory Czarnota, PhD, M.D. (416) 480-6100 ext 7073 email@example.com|
|Principal Investigator:||Gregory Czarnota, PhD, M.D.||Sunnybrook Health Sciences Centre|