MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

Completed

Conditions studied: Prostate Cancer, Hypothermia, Urinary Incontinence, Erectile Dysfunction

In brief

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand: 1. How effectively the tissues for continence and sexual function are cooled within the pelvis. 2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and 3. Determine if the endorectal balloon can be re-designed for improved QOL outcomes in men. This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non-invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non-invasive technique, and answer formidable questions of the effectiveness of hypothermic cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

Key facts

Study ID

NCT01979848

Run by

University of California, Irvine

People needed

3

Starts

2013-06-01

Expected to finish

2015-11-01

Last updated by the study team

2016-12-13

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• A male older than 21 years of age and under age of 80 who does not have prostate cancer and is not enrolled in UCI HS# 2008-6397 (2 male adults to test the MR Temperature Mapping calibration).
• a. CONTROLS: Option for two non-cancer adult male volunteers > 21 years old, to test MR Temperature Mapping calibration. These men are not scheduled for / will not undergo the prostatectomy and related thermometry MRI.
• A male older than 40 years of age who has confirmed prostate cancer and has decided to receive prostatectomy; and have enrolled in UCI HS# 2008-6397 or will be receiving the Endorectal Cooling balloon outside of UCI HS# 2008-6397 as part of a compassionate use.

You may not qualify if…

• Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
• Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
• Have a history of renal disease and determined by the doctor not suitable for receiving injection of MR contrast agent,
• Unable to lie down still for 60 minutes.
• Woman or minor

Where it is running

• University of California, Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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