Liver TumoursNCT02827786
Feasibility of Electromagnetic Acoustic Imaging of Liver Tumours
A study testing Electromagnetic Acoustic Imaging in people with Liver Tumours, run by Enhanced Medical at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumours
- What is being tested?
- Electromagnetic Acoustic Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Focal liver lesion ≥ 1.5cm
- Pre-determined focal liver lesion in location likely easily visible on US
- Ability to provide written informed consent to participate in the study
Who cannot join
- Pregnant or possibility of pregnancy
- Cardiac pacemaker implanted cardioverter- defibrillator, neuro-stimulation system, hepatobiliary metallic foreign body or tattoo at proposed site of imaging.
- Indeterminate focal liver lesion by conventional US, CT and/or MRI imaging and without the prospect of histopathological assessment of lesion(s)
- Local and/or systemic treatment related to focal liver lesion, prior to EMA imaging.
- Inability to obtain imaging and/or acceptable quality of grey-scale and/or EMA imaging
Trial locations and contacts
1 site in 1 country.
Vivek Thayalasuthan, Ph.D contact
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Vivek Thayalasuthan, Ph.D, +1 (416) 480-6100 ext. 89416, Thayalasuthan.Vivekanandan@sunnybrook.ca
Chirag Patel, MD
About this study
Official title: Feasibility of Electromagnetic Acoustic Imaging of Liver Tumours - A Pilot Study
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.
Read the detailed description
STUDY DESIGN Population Single centre pilot study enrolling 30 patients. The study population will comprise of adult patients with documented and characterized focal liver lesion(s) (malignant and/or benign) based on imaging performed at Sunnybrook Health Sciences Centre.
Target lesions and background liver to be studied include:
- Malignant tumours (metastases (adenocarcinomas and neuroendocrine tumours) and primary hepatic malignancy)
- Benign tumours (haemangiomas, focal nodular hyperplasia and adenomas)
- Background liver (remote from target lesion), both normal and fatty liver parenchyma will be included.
Participants must meet the strict inclusion/exclusion criteria for study participation.
Enrollment
- Patients referred for medical imaging at Sunnybrook Health Sciences Centre and have imaging findings consistent with focal hepatic lesion(s) on conventional US, CECT and/or MRI, characteristic of a specific hepatic tumour (benign or malignant), greater than 1.5cm in size and located within a portion of the liver readily amenable to US assessment. An abdominal radiologist and/or surgical oncologist will identify patients. Recruitment will occur prior to baseline imaging (at time of imaging requisition receipt) or immediately following baseline imaging, either by the study coordinator or surgical oncologist.
- Patients referred for imaged guided percutaneous biopsy of a focal liver lesion will also be identified and recruited in advance of their biopsy appointment/intervention, either by the study coordinator or referring surgical oncologist (at time of receiving or requesting biopsy respectively).
- In all cases the responsible physician for the patient will be informed of the intent of the participant, in advance of EMA imaging, thus ensuring recruitment occurs within the circle of care.
Imaging
All EMA imaging will be performed using an investigational EMA device/system, located within the Department of Medical Imaging, Sunnybrook Health Sciences Centre.
Informed consent will be obtained at time of study enrollment, but re-confirmed at time of the EMA study.
Pre-determined target liver lesion(s) (based on baseline diagnostic CT, US or MRI) will be reviewed by an experienced board certified radiologist. Target lesion will be initially evaluated with conventional b-mode US imaging to identify lesion location, size and morphology. Technical feasibility of EMA imaging will be evaluated (imaging window, adequate breath hold etc).
Target lesion will be imaged in two planes (sagittal and transverse) with b-mode, with up to two target lesions assessed per patient. One focal site of background liver parenchyma will also be assessed, remote from the target lesion.
Grey-scale tissue characteristics will be recorded of the target and background parenchyma, including target size, location, and morphology with lesion assigned a conspicuity score by the operator.
EMA imaging will be performed using a dedicated experimental EMA system. Imaging of the pre-determined target lesion(s) and background liver parenchyma will be acquired (see detailed EMA imaging technique below), on a single plane with pre-set region of interest. Qualitative and quantitative parameters will be recorded/stored on the imaging system.
No oral or intravenous contrast agents will be used during this EMA study. Standard or modified ultrasound coupling gel will be used routinely as per standard clinical practice.
Integration with Standard Treatment of Liver Cancer Conventional US together with EMA imaging will be the only additional test/intervention performed as part of this study that are not routinely done for the study population.
Patients will receive standard work-up, treatment and follow-up for their liver lesion(s) according to clinical guidelines and institutional policies. Management and/or treatment will not be modified based on the results of this study.
- Conditions
- Liver Tumours
- Being tested
- Electromagnetic Acoustic Imaging
- Keywords
- hepatic tumours
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Acoustic ImagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic Acoustic Imaging | Experimental | Not described Receives: Device: Electromagnetic Acoustic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 18 months
Secondary outcomes (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.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enhanced Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Chirag Patel, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827786
- Sponsor's protocol ID
- EMASunnybrook1
- Status last verified
- Jul 2016
- First submitted
- 18 Mar 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Electromagnetic Acoustic Imaging of Liver Tumours - A Pilot Study
- ClinicalTrials.gov ID
- NCT02827786
- Acronym / sponsor ID
- EMASunnybrook1
- Conditions
- Liver Tumours
- Keywords
- hepatic tumours
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Enhanced MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY DESIGN Population Single centre pilot study enrolling 30 patients. The study population will comprise of adult patients with documented and characterized focal liver lesion(s) (malignant and/or benign) based on imaging performed at Sunnybrook Health Sciences Centre.
Target lesions and background liver to be studied include:
- Malignant tumours (metastases (adenocarcinomas and neuroendocrine tumours) and primary hepatic malignancy)
- Benign tumours (haemangiomas, focal nodular hyperplasia and adenomas)
- Background liver (remote from target lesion), both normal and fatty liver parenchyma will be included.
Participants must meet the strict inclusion/exclusion criteria for study participation.
Enrollment
- Patients referred for medical imaging at Sunnybrook Health Sciences Centre and have imaging findings consistent with focal hepatic lesion(s) on conventional US, CECT and/or MRI, characteristic of a specific hepatic tumour (benign or malignant), greater than 1.5cm in size and located within a portion of the liver readily amenable to US assessment. An abdominal radiologist and/or surgical oncologist will identify patients. Recruitment will occur prior to baseline imaging (at time of imaging requisition receipt) or immediately following baseline imaging, either by the study coordinator or surgical oncologist.
- Patients referred for imaged guided percutaneous biopsy of a focal liver lesion will also be identified and recruited in advance of their biopsy appointment/intervention, either by the study coordinator or referring surgical oncologist (at time of receiving or requesting biopsy respectively).
- In all cases the responsible physician for the patient will be informed of the intent of the participant, in advance of EMA imaging, thus ensuring recruitment occurs within the circle of care.
Imaging
All EMA imaging will be performed using an investigational EMA device/system, located within the Department of Medical Imaging, Sunnybrook Health Sciences Centre.
Informed consent will be obtained at time of study enrollment, but re-confirmed at time of the EMA study.
Pre-determined target liver lesion(s) (based on baseline diagnostic CT, US or MRI) will be reviewed by an experienced board certified radiologist. Target lesion will be initially evaluated with conventional b-mode US imaging to identify lesion location, size and morphology. Technical feasibility of EMA imaging will be evaluated (imaging window, adequate breath hold etc).
Target lesion will be imaged in two planes (sagittal and transverse) with b-mode, with up to two target lesions assessed per patient. One focal site of background liver parenchyma will also be assessed, remote from the target lesion.
Grey-scale tissue characteristics will be recorded of the target and background parenchyma, including target size, location, and morphology with lesion assigned a conspicuity score by the operator.
EMA imaging will be performed using a dedicated experimental EMA system. Imaging of the pre-determined target lesion(s) and background liver parenchyma will be acquired (see detailed EMA imaging technique below), on a single plane with pre-set region of interest. Qualitative and quantitative parameters will be recorded/stored on the imaging system.
No oral or intravenous contrast agents will be used during this EMA study. Standard or modified ultrasound coupling gel will be used routinely as per standard clinical practice.
Integration with Standard Treatment of Liver Cancer Conventional US together with EMA imaging will be the only additional test/intervention performed as part of this study that are not routinely done for the study population.
Patients will receive standard work-up, treatment and follow-up for their liver lesion(s) according to clinical guidelines and institutional policies. Management and/or treatment will not be modified based on the results of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic Acoustic Imaging | Experimental | Device: Electromagnetic Acoustic Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Focal liver lesion ≥ 1.5cm
- Pre-determined focal liver lesion in location likely easily visible on US
- Ability to provide written informed consent to participate in the study
Key exclusion criteria (5 listed)
- Pregnant or possibility of pregnancy
- Cardiac pacemaker implanted cardioverter- defibrillator, neuro-stimulation system, hepatobiliary metallic foreign body or tattoo at proposed site of imaging.
- Indeterminate focal liver lesion by conventional US, CT and/or MRI imaging and without the prospect of histopathological assessment of lesion(s)
- Local and/or systemic treatment related to focal liver lesion, prior to EMA imaging.
- Inability to obtain imaging and/or acceptable quality of grey-scale and/or EMA imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic Acoustic ImagingElectromagnetic 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. | Device | Electromagnetic Acoustic Imaging |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Thayalasuthan, Ph.D contact
Chirag Patel, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Acoustic Imaging in people with Liver Tumours, run by Enhanced Medical at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivek Thayalasuthan, Ph.D (+1 (416) 480-6100 ext. 89416, Thayalasuthan.Vivekanandan@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.