LUMINITY®422
Research type
Research Study
Full title
A Multicentre, Parallel-Group, Randomized, Cross-over Trial To Compare the Efficacy of LUMINITY® and SonoVue® in the Evaluation of Left Ventricular Endocardial Border Definition
IRAS ID
225826
Contact name
Cesare Orlandi
Contact email
Sponsor organisation
Lantheus MI UK Limited
Clinicaltrials.gov Identifier
will be provided by Sponsor, ENCePP Registration Number
Duration of Study in the UK
0 years, 9 months, 25 days
Research summary
This study is designed to compare the effectiveness and safety of two ultrasound contrast agents, Luminity® and SonoVue®, which are both approved for use in Europe and are used to enhance the echocardiogram. An echocardiogram or "echo", is a type of ultrasound scan used to look at the heart and nearby blood vessels. The contrast is used in order to make the scan picture clearer and to allow a more accurate assessment of the heart’s function.
The study will be conducted in approximately 4 hospital sites in the UK; approximately 148 adult patients, who are scheduled to undergo a resting echocardiogram for clinical reasons, will be enrolled and will be in the study for up to 9 days. Patients, aged 18 years and over, of all races, gender and ethnicity will be considered if they meet the criteria for inclusion.
Each patient will have 3 echocardiograms, the first will be unenhanced (no contrast agent will be given) at screening. Prior to the second echocardiogram patients will receive the first contrast agent, either Luminity or SonoVue. Prior to the third echocardiogram patients will receive the second contrast agent (either Luminity or SonoVue); the order in which Luminity and SonoVue are given will be randomly assigned. After each contrast agent is given, either by intravenous injection (injection directly into a vein) or intravenous infusion (infusion directly into a vein), the patient will have an echocardiogram. There will be a period of 4-72 hours between each contrast agent/echocardiogram and patients will remain at site for observation until at least 30 minutes after the end of the administration of the study drug and/or comparator. Patients will be followed up by a telephone call approximately 24 +8 hours after session.
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/0783
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion