1. Pixels and pills: why clinical trial
imaging?
All aspects of image acquisition and handling in
image-based clinical trials are highly regulated,
complex, and multidisciplinary. All steps are strictly
monitored and vary widely from Region-of-Interest
to Return-on-Investment. Even in those cases where
the imaging component is not a study endpoint, the
images acquired as part of a normal clinical evalua-
tion often become a key component at later stages.
This is particularly true when patients are included
in phase 2 and 3 studies, but have to be excluded
when the MRI, PET or CT scans were of poor image
quality or not evaluable, even if they otherwise met
the patient selection criteria. Additionally, some key
advantages of clinical trial imaging are the ability to
evaluate the in-vivo behaviour of a drug, including the
pharmacokinetics through uptake, biodistribution &
excretion, and where necessary comparison with the
pre-clinical data.
Why an imaging CRO?
The central coordination by an independent imaging
company, with specific modality and therapeutic
expertise, is the only guarantee for uniform image
acquisition, independent KOL reader selection and
adjudication, optimal image modality determination,
image query handling, image phantom management,
and resolution of unanticipated firewall issues. Inte-
gration of the image workflow and the clinical work-
flow is essential, and regularly proves to be difficult.
Why Lyscaut?
Lyscaut Medical Imaging Company is an independent
imaging core lab and image contract research organi-
sation, with advanced multi-disciplinary expertise,
having administrative HQ in Belgium, with country
specific offices in France, UK and USA.
› Lyscaut is small enough to care but large
enough to deliver. Similar in-house expertise
and technical project management tends to only
be available in (very) large imaging CROs. This
ability to provide a truly bespoke and personalised
service for Clients sets Lyscaut apart from the com-
petition. Lyscaut offers cost-conscious technical
project management, in depth level of understand-
ing and unprecedented flexibility in design, support
and implementation – whether end-to-end, at any
stage, in any role, or in an all-out rescue effort.
Lyscaut: clarity from concept to conclusion.

2. Our Client base consists of pharma, biotechnology
& contract research and academia-based KOL inves-
tigators – all expecting and receiving the necessary
support to ensure their clinical trials and projects
meet the expected outcomes.
› Lyscaut is an integrated provider of both imaging
and clinical support. This makes the involvement
of an additional clinical CRO redundant and avoids
overlap, creates efficiencies and lowers costs. Many
image-based clinical studies typically rely on a hetero-
geneous mix of both imaging and clinical data with
the emphasis on imaging. As the clinical information
is linked to the imaging data, it is beneficial to inte-
grate these for efficient use of project management
and monitoring resources. The clinical part of plan-
ning and project management is, comparatively, less
technically challenging and more platform-independ-
ent than the imaging handling and management.
Resource use for the clinical project management
and monitoring is driven less by technical complexi-
ties and challenges than by guidelines and practices.
These make it mandatory that time is spent on moni-
toring, source data verification, query-resolutions and
data management. Technical difficulties and the need
for qualified personnel are typically an issue in the
imaging area than in the clinical area of the project.
› Lyscaut has a focus on personalised medicine
that separates patients into different groups — with
medical decisions, practices, interventions and/or
products being tailored to the individual patient
based on their predicted response or risk of disease.
This theranostic approach brings improved thera-
peutic management and typically combines diag-
nostic and therapeutic medicine on a molecular
marker level: from diagnostic target identification to
therapeutic target modification.
Lyscaut: different partners,
same success.
Lyscaut is an image service provider that integrates
cutting-edge technology in image logistics, visualisa-
tion and analysis, with in-house expertise, providing
a cost-effective and bespoke solution. Lyscaut is well
Image provided by courtesy of Hermes Medical Solutions (Sweden) and Lightpoint Medical (UK). All rights reserved.

3. positioned to fill gaps in any pharmaceutical program
or study. Hermes Medical is the principal technology
provider for scanner-independent image handling.
Lyscaut is also able to incorporate other customized
image logistics platform(s) tailored per trial and post
processing software optimized per scanner ultimately
saving time, effort and money. The focus is always on
workflow optimisation, image quality and regulatory
compliance.
Lyscaut: comprehensive, scalable and
accountable.
Lyscaut leverages the latest technologies behind the
core lab services to improve productivity and operate
more efficiently. Lyscaut brings a depth of experience
in a broad range of clinical areas and more specifi-
cally within the areas of body composition, inflamma-
tion, oncology, cardiology, neurology and gastroen-
terology. A key advantage of working with a smaller
company is the ability to provide a bespoke and more
personalised package and also a range of services to
complement or supplement what is already on offer.
Rapport is our mindset.
Core lab services:
- Multi-modality biomarker selection and development
- Imaging charter development & document preparation
- Scientific & medical consultancy
- Study protocol design & financial modeling
- Imaging KOL and reader network selection
- Study roll-out and management
- Site training and certification
- End-to-end image logistics, processing and analysis
- Data logging, tracking & reporting and quality control
- Regulatory and compliance support throughout
- Study close-out reporting
- Publication support and oversight
Emerging technologies:
- Optical molecular imaging (fluorescence, confocal
laser, Cerenkov) in support of image-guided surgery
- Hybrid molecular imaging (SPET - PET - MRI - CT)
- Hyperpolarised molecular imaging (DNP - MRI)
- Metabolic imaging (MRI mapping, qCT, US, DEXA)
Areas of expertise:
- Oncology
- Neurology
- Cardiology
- Gastroenterology
- Inflammation
- Body composition
Lyscaut
optical
imaging
hybrid
imaging
hyperpolarised
imaging
metabolic
imaging
gastro-enterology
neurology
cardiology
oncology
inflammation
body composition
personalised
medicine
molecular
markers

4. Lyscaut:
delivering a new
perspective in
clinical outcomes
www.lyscaut.com
Contact EU:
EU@lyscaut.com
Phone: +32-479-838710
Contact USA:
USA@lyscaut.com
Phone: +1-646-736-2487
Contact UK:
UK@lyscaut.com
Phone: +44-7968-042585