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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
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Enhanced Medical

Brief Summary:
A single-centre, industry sponsored, proof-of-concept pilot study to assess the feasibility of Electromagnetic Acoustic Imaging (EMA) as an imaging platform in the visualization of hepatic tumours.

Condition or disease Intervention/treatment Phase
Liver Tumours Device: Electromagnetic Acoustic Imaging Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnostic liver imaging (US, CT or MRI) prior to enrolment demonstrating characteristic (benign or malignant) focal liver lesion with classic imaging features or focal liver lesion that will undergo histopathological analysis (percutaneous biopsy or surgical resection) following EMA imaging.
  2. Focal liver lesion ≥ 1.5cm
  3. Pre-determined focal liver lesion in location likely easily visible on US
  4. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  1. Pregnant or possibility of pregnancy
  2. Cardiac pacemaker implanted cardioverter- defibrillator, neuro-stimulation system, hepatobiliary metallic foreign body or tattoo at proposed site of imaging.
  3. Indeterminate focal liver lesion by conventional US, CT and/or MRI imaging and without the prospect of histopathological assessment of lesion(s)
  4. Local and/or systemic treatment related to focal liver lesion, prior to EMA imaging.
  5. Inability to obtain imaging and/or acceptable quality of grey-scale and/or EMA imaging

Information from the National Library of Medicine

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


Contacts
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Contact: Vivek Thayalasuthan, Ph.D +1 (416) 480-6100 ext 89416 Thayalasuthan.Vivekanandan@sunnybrook.ca

Locations
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Canada, Ontario
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         
Sponsors and Collaborators
Enhanced Medical
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Chirag Patel, MD Sunnybrook Health Sciences Centre

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Responsible Party: Enhanced Medical
ClinicalTrials.gov Identifier: NCT02827786     History of Changes
Other Study ID Numbers: EMASunnybrook1
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Enhanced Medical:
hepatic tumours

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases