NCT02827786

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

March 18, 2016

Last Update Submit

July 8, 2016

Conditions

Liver Tumours

Keywords

hepatic tumours

Outcome Measures

Primary Outcomes (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.

    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.

    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.

    18 months

Study Arms (1)

Electromagnetic Acoustic Imaging

EXPERIMENTAL
Device: Electromagnetic Acoustic Imaging

Interventions

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.

Electromagnetic Acoustic Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Chirag Patel, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivek Thayalasuthan, Ph.D

CONTACT

+1 (416) 480-6100Thayalasuthan.Vivekanandan@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

July 11, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)