Evaluation of MRI for Prostate Cancer

This study has been terminated.

(The MRI company forbidded additional scans with endorectal colil in this machine)

Sponsor:

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00930748

First received: June 22, 2009

Last updated: June 24, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 22, 2009
Last Updated Date	June 24, 2011
Start Date ^ICMJE	November 2008
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 29, 2009)	• MRI and pathology correlation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00930748 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	Evaluation of MRI for Prostate Cancer
Official Title ^ICMJE	Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer
Brief Summary	The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.
Detailed Description	The objective of this study is to evaluate of the potential of endorectal 3T MRI for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	patients with prostate cancer
Condition ^ICMJE	Prostatic Neoplasms
Intervention ^ICMJE	Device: MR imaging with endorectal coil MR imaging with endorectal coil Device: MRI with endo-rectal coil MRI with endo-rectal coil
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	40
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age of patients: up to 80 years. Men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence. Patients who are able and willing to give consent and able to have an MRI examination. Exclusion Criteria: Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Dotarem) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.) Any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani) Any spinal pathology that prohibits maintaining supine position for an hour Patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Gender	Male
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00930748
Other Study ID Numbers ^ICMJE	SHEBA-08-4965-OP-CTIL
Has Data Monitoring Committee	No
Responsible Party	Dr. Orith Portnoy, Sheba Medical Center
Study Sponsor ^ICMJE	Sheba Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sheba Medical Center
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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