Evaluation of MRI for Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00930748
• Other study ID #: SHEBA-08-4965-OP-CTIL
• Status: Terminated
• Phase: Phase 2
• First received: June 22, 2009
• Last updated: June 24, 2011
• Start date: November 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• MRI and pathology correlation		2 years	No