Trial record 1 of 1 for:
01007214
Guided Biopsy for Mapping Prostate Cancer (HIT)
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ClinicalTrials.gov Identifier: NCT01007214 |
Recruitment Status
:
Terminated
(Not able to meet accrual)
First Posted
: November 3, 2009
Last Update Posted
: February 27, 2014
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Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
Tracking Information | ||||
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First Submitted Date ICMJE | October 29, 2009 | |||
First Posted Date ICMJE | November 3, 2009 | |||
Last Update Posted Date | February 27, 2014 | |||
Study Start Date ICMJE | May 2010 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. [ Time Frame: Six years ] | |||
Original Primary Outcome Measures ICMJE |
Determine accuracy of hybrid image technology guided biopsies for prostate cancer mapping. [ Time Frame: 8/2010 ] | |||
Change History | Complete list of historical versions of study NCT01007214 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Guided Biopsy for Mapping Prostate Cancer | |||
Official Title ICMJE | Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy | |||
Brief Summary | Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy. | |||
Detailed Description | The objective of this study is to determine the accuracy of HIT (Hybrid Imaging Technology) guided biopsies for mapping tumor foci with men undergoing prostatectomy. Using a prostate hybrid imaging technology (HIT) which fuses a previously obtained endorectal MR image to transrectal ultrasound (TRUS) image to allow identification and biopsy of tumors by MR imaging in real time. We hypothesis that HIT guided biopsies will accurately localize the foci of prostate cancer. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE | Procedure: Prostatectomy
Elective prostatectomy
Other Name: Prostate cancer |
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Study Arms | Experimental: Prostate cancer
A total of 30 patients diagnosed with prostate cancer who have elected to undergo radical prostatectomy are enrolled over a six year period.
Intervention: Procedure: Prostatectomy |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
7 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date | February 2014 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Inclusion of minorities:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01007214 | |||
Other Study ID Numbers ICMJE | I 133608 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Roswell Park Cancer Institute | |||
Study Sponsor ICMJE | Roswell Park Cancer Institute | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Roswell Park Cancer Institute | |||
Verification Date | February 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |