Liver Tumours Clinical Trial
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.
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:
1. Malignant tumours (metastases (adenocarcinomas and neuroendocrine tumours) and primary
hepatic malignancy)
2. Benign tumours (haemangiomas, focal nodular hyperplasia and adenomas)
3. 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
1. 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.
2. 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).
3. 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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic