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Evaluation of MRI for Prostate Cancer

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. Read our disclaimer for details. Identifier: NCT00930748
Recruitment Status : Terminated (The MRI company forbidded additional scans with endorectal colil in this machine)
First Posted : June 30, 2009
Last Update Posted : June 27, 2011
Information provided by:
Sheba Medical Center

Brief Summary:
The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.

Condition or disease Intervention/treatment
Prostatic Neoplasms Device: MR imaging with endorectal coil Device: MRI with endo-rectal coil

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

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer
Study Start Date : November 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Device: MR imaging with endorectal coil
    MR imaging with endorectal coil
  • Device: MRI with endo-rectal coil
    MRI with endo-rectal coil

Primary Outcome Measures :
  1. • MRI and pathology correlation [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with prostate cancer

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930748

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Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Dr. Orith Portnoy, Sheba Medical Center Identifier: NCT00930748     History of Changes
Other Study ID Numbers: SHEBA-08-4965-OP-CTIL
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases