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NCT01979848 · ClinicalTrials.gov registry record
MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon
A clinical trial, sponsored by University of California, Irvine.
- Completed
- Registry status
- 3
- Enrollment target
NCT01979848: Completed study, sponsored by University of California, Irvine.
NCT01979848 is a clinical trial that has completed, run by University of California, Irvine. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01979848 has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
During pre and post hypothermia, initial temperatures will be measured simultaneously on five 3-mm-thick image slices that covered the target. The thermometry scan can be repeated every 6 s. Tissue temperature map is measured by magnetic resonance thermometry (echo planar imaging with multiphase; field of view: 25 × 25 cm; matrix 256 × 256; number of excitations: 1; repetition time: 545 ms; echo time: 20 ms; flip angle: 20°; slice thickness: 3 mm); (b) a thermal map of the tissue volume will be
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-11 |
What the finished NCT01979848 record still lists
NCT01979848 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01979848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01979848 about?
NCT01979848 is a clinical study titled "MRI 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 inconti...
What is the current status of trial NCT01979848?
This trial is currently completed. The enrollment target is 3 participants. The study started on 2013-06. Estimated completion is 2015-11.
Who is sponsoring clinical trial NCT01979848?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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