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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

June 22, 2009
June 24, 2011
November 2008
June 2011   (final data collection date for primary outcome measure)
• MRI and pathology correlation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930748 on ClinicalTrials.gov Archive Site
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Evaluation of MRI for Prostate Cancer
Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer

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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

patients with prostate cancer

Prostatic Neoplasms
  • Device: MR imaging with endorectal coil
    MR imaging with endorectal coil
  • Device: MRI with endo-rectal coil
    MRI with endo-rectal coil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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)
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00930748
SHEBA-08-4965-OP-CTIL
No
Dr. Orith Portnoy, Sheba Medical Center
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP