Evaluation of MRI for Prostate Cancer

NCT00930748 | Terminated

• 1 other identifier: SHEBA-08-4965-OP-CTIL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• • MRI and pathology correlation

  2 years

Interventions

MR imaging with endorectal coil DEVICE

MR imaging with endorectal coil

MRI with endo-rectal coil DEVICE

MRI with endo-rectal coil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with prostate cancer

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 30, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

IL (1)