Evaluation of MRI for Prostate Cancer

NCT ID: NCT00930748

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Prostatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MR imaging with endorectal coil

MR imaging with endorectal coil

Intervention Type DEVICE

MRI with endo-rectal coil

MRI with endo-rectal coil

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-08-4965-OP-CTIL

Identifier Type: -

Identifier Source: org_study_id

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