Feasibility of Electromagnetic Acoustic Imaging of Liver Tumours
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|ClinicalTrials.gov Identifier: NCT02827786|
Recruitment Status : Unknown
Verified July 2016 by Enhanced Medical.
Recruitment status was: Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Liver Tumours||Device: Electromagnetic Acoustic Imaging||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Electromagnetic Acoustic Imaging of Liver Tumours - A Pilot Study|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||May 2017|
|Experimental: Electromagnetic Acoustic Imaging||
Device: Electromagnetic Acoustic Imaging
Electromagnetic Acoustic imaging (EMA) is a novel experimental platform utilizing the combination of electromagnetic radio frequency (RF) and acoustic waves to enhance ultrasound images. The resultant imaging allows (based on early experimental models) tissue differentiation based on its mechanical and electrical properties. Combined with conventional US scanning, this technology potentially allows high spatial resolution imaging of a target tissue with superimposed high contrast functional information. This is a proof-of-concept pilot study in humans.
- EMA (colour scale) images will be compared to baseline US grey-scale images for a specific target lesion, as determined by standard of care imaging (US, CT, MRI or PET) and/or histologically proven lesion in a given subject. [ Time Frame: 18 months ]EMA (colour scale) images will be compared to baseline US grey-scale images for a specific target lesion, as determined by standard of care imaging (US, CT, MRI or PET) and/or histologically proven lesion in a given subject. EMA colour maps and fused EMA colour with grey-scale US imaging will be assigned a binary outcome for lesion detection (yes/no) and positive results will be graded along a categorical incremental scale with respect to level of EMA signal (i.e. 0 (no signal), 1 (minimal signal), 2 (mild signal) to 5 (good)). Expert readers in diagnostic imaging will obtained outcome measures visually.
- US grey-scale and EMA colour maps will be obtained from both target liver lesions and background liver tissue from the same subject and compared. [ Time Frame: 18 months ]US grey-scale and EMA colour maps will be obtained from both target liver lesions and background liver tissue from the same subject. Comparison will be made visually for difference in signal (grey-scale and colour respectively) between lesion and background liver. Differences will be assigned a binary classification (yes/no) and graded according level of difference (small, medium or large). Expert readers in diagnostic imaging will obtained outcome measures visually.
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): NCT02827786
|Contact: Vivek Thayalasuthan, Ph.D||+1 (416) 480-6100 ext 89416||Thayalasuthan.Vivekanandan@sunnybrook.ca|
|Sunnybrook Health Sciences Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Vivek Thayalasuthan, Ph.D +1 (416) 480-6100 ext 89416 Thayalasuthan.Vivekanandan@sunnybrook.ca|
|Principal Investigator: Chirag Patel, MD|
|Sub-Investigator: Masoom Haider, MD|
|Principal Investigator:||Chirag Patel, MD||Sunnybrook Health Sciences Centre|