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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00824902 |
Purpose
The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer.
As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Procedure: Tissue Elastography Imaging |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Tissue Elastography Imaging
|
Procedure: Tissue Elastography Imaging
Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.
|
Study Imaging:
As part of routine care, ultrasound scanning is commonly used to find the cancerous areas of the prostate before the prostate is surgically removed. The ultrasound images are in black, white, and gray, and the dark areas may show prostate cancer.
In this study, standard ultrasound scanning will still be done, but researchers want to test another form of diagnostic imaging called tissue elastography.
Tissue elastography uses the same machine and probe as the ultrasound. The probe is gently pushed through the rectum and into the prostate gland (similar to a digital rectal exam). The ultrasound machine will use a special elastography software that is designed to scan the prostate for differences in how hard the tissue is. Prostate cancer tissue may be harder than surrounding tissue, and the images produced by tissue elastography are designed to show these differences in hardness of tissue.
Screening:
Before you can join this study, the study staff will review the results of your most recent prostate ultrasound and biopsy. This is a "screening" procedure to help the doctor decide if you are eligible to take part in this study.
Study Procedures:
If you are found to be eligible to take part in this study, tissue elastography imaging will be performed during your routine ultrasound before prostate surgery. The probe, once inserted, will be gently pressed against the prostate a few times in order to perform the tissue elastography. The routine ultrasound part of the procedure should take about 10 minutes, and the elastography should take about 10-15 minutes.
Length of Study Participation:
Your active participation in this study will be over after the tissue elastography imaging. The routine ultrasound will be the main decision-making exam. However, if the tissue elastography imaging shows something different and possibly related to your care, your doctor will be informed.
After the prostate is removed and the tissue results are available, researchers will compare the tissue results with the tissue elastography images. You will not receive the results of the tissue elastography imaging, as the imaging is being used for research only.
This is an investigational study. The ultrasound machine and probe that are used for the tissue elastography in this study are FDA approved for ultrasound scanning. Performing tissue elastography for prostate cancer detection is investigational. At this time and for this purpose, tissue elastography is only being performed in research.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John W. Davis, MD | 713-792-3250 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: John W. Davis, MD | |
| Principal Investigator: | John W. Davis, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( John W. Davis, MD/Assistant Professor ) |
| Study ID Numbers: | 2007-0949 |
| Study First Received: | January 15, 2009 |
| Last Updated: | January 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00824902 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Prostate Cancer Prostate Radical Prostatectomy Tissue Elastography |
Tissue Elastography Imaging Software Program Measuring Prostate Elasticity Elasticity/Tissue Strain-Hardening Imaging Ultrasound |
|
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
