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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
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
Device: MR imaging with endorectal coil
Device: MRI with endo-rectal coil
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • • MRI and pathology correlation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MR imaging with endorectal coil
    MR imaging with endorectal coil
    Device: MRI with endo-rectal coil
    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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with prostate cancer

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930748

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Orith Portnoy, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00930748     History of Changes
Other Study ID Numbers: SHEBA-08-4965-OP-CTIL
Study First Received: June 22, 2009
Last Updated: June 24, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on November 20, 2014