MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Erectile Dysfunction, Overactive Bladder, Hospital, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Oncology, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/14/2016 |
| Start Date: | June 2013 |
| End Date: | November 2015 |
MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon
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.
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.
Prostate cancer is the second most frequent cause of cancer death in men and it accounts for
11% of all male cancers. Radical prostatectomy remains the gold standard for localized
disease, offering the advantage of precise staging and grading and the real possibility of
disease eradication. In the US there are approximately 100,000 radical prostatectomies (RP)
performed for prostate cancer annually. However, there are two major challenges to the
quality of life outcomes after radical prostatectomy: preserving urinary continence, and
sexual function. The quality of life (QOL) after radical prostatectomy relies on the return
of continence and sexual function after surgery to their pre‐operative 'normal' status. The
main factor which determines potency rates for patients is whether or not the nerves at the
Neurovascular Bundles (NVB), are spared, and it may take years for sexual function to
return. This may be due to the nerve injury from the nerve trauma in the surgical procedure.
Similarly, a major factor involved in post‐radical prostatectomy incontinence is
preservation of the nerves that control the external urethral sphincter, bladder, and
urogenital diaphragm. Also Inflammation from surgical removal of the prostate not only
affects nerves, but also may directly damage the bladder, urethra, and pelvic floor.
Effective strategies to prevent this damage are currently lacking. One stratagem to prevent
or minimize such damage, is the use of local hypothermia with ice or cold irrigation around
the nerves and tissues prior to, during, and after the injury has occurred. In numerous
experimental models of central and peripheral nervous system injury, the use of moderate
hypothermia (i.e. 28‐33oC) has been shown to provide dramatic neuroprotection safely in
humans, during cardiac, kidney, and brain surgery for many years.
11% of all male cancers. Radical prostatectomy remains the gold standard for localized
disease, offering the advantage of precise staging and grading and the real possibility of
disease eradication. In the US there are approximately 100,000 radical prostatectomies (RP)
performed for prostate cancer annually. However, there are two major challenges to the
quality of life outcomes after radical prostatectomy: preserving urinary continence, and
sexual function. The quality of life (QOL) after radical prostatectomy relies on the return
of continence and sexual function after surgery to their pre‐operative 'normal' status. The
main factor which determines potency rates for patients is whether or not the nerves at the
Neurovascular Bundles (NVB), are spared, and it may take years for sexual function to
return. This may be due to the nerve injury from the nerve trauma in the surgical procedure.
Similarly, a major factor involved in post‐radical prostatectomy incontinence is
preservation of the nerves that control the external urethral sphincter, bladder, and
urogenital diaphragm. Also Inflammation from surgical removal of the prostate not only
affects nerves, but also may directly damage the bladder, urethra, and pelvic floor.
Effective strategies to prevent this damage are currently lacking. One stratagem to prevent
or minimize such damage, is the use of local hypothermia with ice or cold irrigation around
the nerves and tissues prior to, during, and after the injury has occurred. In numerous
experimental models of central and peripheral nervous system injury, the use of moderate
hypothermia (i.e. 28‐33oC) has been shown to provide dramatic neuroprotection safely in
humans, during cardiac, kidney, and brain surgery for many years.
Inclusion Criteria:
1. 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.
2. 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.
Exclusion Criteria:
1. Have implanted prosthetic heart valves, pacemaker, neuro‐stimulation devices,
surgical clips (hemostatic clips) or other metallic implants,
2. Have engaged in occupations or activities which may cause accidental lodging of
ferromagnetic materials, or have imbedded metal fragments from military activities,
3. Have a history of renal disease and determined by the doctor not suitable for
receiving injection of MR contrast agent,
4. Unable to lie down still for 60 minutes.
5. Woman or minor
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