Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5260
Study information
Scientific title
Acronym
Ultrasound Elastography
Study hypothesis
Ultrasound elastography is a non-invasive ultrasound method which evaluates the deformability of a structure. The principle of elastography is the utilisation of tissue compression producing varying levels of strain within different tissue types. 'Strain images' obtained can then be analysed to assess the mechanical properties of tissues and infer their size and nature.
Ethics approval
MREC approved (ref: 07/H0306/90)
Study design
Single centre non-randomised interventional diagnosis, prevention and screening trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Other
Intervention
Ultrasound elastography
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Assess the ability to obtain strain images from different tissues of the body, e.g. abdomen, pelvis, head and neck, breast, testes and soft tissues
Secondary outcome measures
Evaluate accuracy of ultrasound elastography compared with standard ultrasound
Overall trial start date
01/08/2007
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 600
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2007
Recruitment end date
01/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research council
Funder name
Engineering and Physical Sciences Research Council (EPSRC) (UK)
Alternative name(s)
EPSRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
The Wellcome Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary