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|ClinicalTrials.gov Identifier: NCT02290561|
Recruitment Status : Unknown
Verified November 2014 by University College, London.
Recruitment status was: Not yet recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.
The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue.
Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects.
SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation.
The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Procedure: SmartTarget Therapy Device: MRI Device: high intensity focused ultrasound (HIFU)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
- Procedure: SmartTarget Therapy
MRI to Ultrasound fusion directed HIFU
- Device: MRI
- Device: high intensity focused ultrasound (HIFU)
- Target Ablation [ Time Frame: 1 week post treatment ]The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist.
- Accuracy [ Time Frame: 1 week post treatment ]The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment.
- Length of the procedure [ Time Frame: intraoperative ]
The efficiency and clinical usability of the SmartTarget device as measured by the:
Length of the procedure
The time taken during the procedure using SmartTarget, including:
The total prostate computer model generation time The total time taken to register (fuse) MRI and ultrasound image data and the number of times an image registration is performed using SmartTarget (the re-registration rate) SmartTarget failure rate
- Quality of Life [ Time Frame: 6 weeks and 3 months ]
To assess how this treqatment strategy impacts on quality of life as measured using validated questionnaires at 6 weeks and 3 months post treatment.
IPSS IIEF EQ5D - 5L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290561
|Contact: Ian A Donaldson, BMBS MRCS||0044 (0)207 679 email@example.com|
|Principal Investigator:||Hashim U Ahmed, FRCS PhD||University College, London|