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Clinical Feasibility Study of Prototype 1.5T & 3T Endorectal Coils

Clinical Feasibility Study of Prototype 1.5T & 3T Endorectal Coils - Endorectal coil MRI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34331
Enrollment
8
Registered
2011-07-11
Start date
2011-07-12
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Newly diagnosed and biopsy proven prostate cancer • No previous treatment for prostate cancer • Signed informed consent by patient • 18 years of age or more • Signed screening form (to search for metal device/foreign bodies/claustrophobia) • No contraindications for and are eligible to have a MR scan of their prostate utilizing an endorectal coil

Exclusion criteria

Exclusion criteria: • Impossibility to obtain a valid informed consent • Patients unable to undergo MR imaging, including those with contra-indications • Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging

Design outcomes

Primary

MeasureTime frame
Investigational 1.5T and 3.0T Siemens eCoils, tuning devices and the appropriate configuration files to enable use of the coil will be provided for the purpose of this study. Patients will be positioned on the scanner table and the eCoil inserted by an experienced radiologist. All coils will be filled with perfluorocarbon. Patients will then be scanned utilizing the imaging protocol, (pulse sequences noted above) as are normally employed by the radiology department of the RUNMC when performing endorectal prostate MR studies on their patients. Images obtained with the investigational four channel output eCoil in conjunction with or without a surface coil and images obtained using commercial 1.5T endorectal probes with any fluids other than air are NOT to be used for diagnostic purposes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)