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ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01979848
NCT01979848N/ACompleted

MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

University of California, Irvine·observational·Posted Nov 8, 2013·Updated Dec 13, 2016

In Brief

An observational study for Prostate Cancer and 3 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 8, 2013
Enrollment StartJun 1, 2013
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.7 years ago