Patients undergoing pre-operative/follow up MRI investigation for a known enhancing brain tumour
Conditions
Interventions
Trade Name: SonoVue
Product Name: SonoVue®
Pharmaceutical Form: Powder and solvent for dispersion for injection
INN or Proposed INN: Sulphur hexafluoride ( 8 µl/ml)
CAS Number: 2551-62-4
Current Spons
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing pre-operative MRI investigation for a known enhancing intracranial neoplasm. 2. Patients undergoing follow up MRI investigation for an intracranial neoplasm (including residual neoplasm) 3. Patient/ guardian provides written informed consent and is willing to comply with the protocol requirements Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Patients with non-enhancing tumours 2. Contraindications to SonoVue ® (Appendix 1 in the protocol)and/or Gadolinium Allergy to sulphur hexafluoride or sulphur containing medication Known cardiac disorders Adult respiratory distress syndrome • Pregnant and lactating females – All females of child bearing age will have a pregnancy test. 3. Patients with acute or chronic renal disease (risk of gadolinium induced toxicity) 4. Patients with allergic /atopic tendency: History of asthma or allergic reaction to food or drugs leading to urticarial, bronchospasm, hypotension or anaphylactoid reaction. 5. Patients with contraindication to undergo MR imaging (Cochlear implant, pacemaker, claustrophobia etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can cerebral perfusion data can be acquired using SonoVue® in patients with brain tumours undergoing MR imaging ;Secondary Objective: 1 Can SonoVue® as an MRI contrast agent provide more accurate blood perfusion data when compared to the traditional MRI contrast agent(Gadolinium)? 2 Can Tumour blood vessels be better visualised using an MRI technique known as susceptibility weighted imaging after administration of SonoVue® ? 3 Are there any significant side effects with SonoVue® ?;Primary end point(s): Intensity-time curves form DSC perfusion data following intravenous SonoVue®: This is a graph that plots the MRI signal intensity against time. This is obtained from the dynamic susceptibility contrast (DSC) imaging data during intravenous administration of the contrast agent(SonoVue®). The evidence of a reduction in signal intensity during first pass of the contrast agent will confirm the MRI susceptibility contrast property of SonoVue®.;Timepoint(s) of evaluation of this end point: Interim ananlysis will be conducted in each group (adult and paediatric age groups) after 10 cases have undergone MRI scans in that group. If the interim analysis supports continuation of the study, the primary outcome will be evaluated at the end of the the next 20 patients in each group completing the 30 patient cohort in each group(end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Intensity-time curve from Sono Vue® DSC perfusion data indicating presence or absence of contrast leakage. I.e. The post enhancement segment of the intensity-time curve lying at or below the baseline indicates absence of contrast leakage. 2) Post SonoVue® SWI sequence demonstrating presence or absence of intratumoral vessels. 3) Document side effects. ;Timepoint(s) of evaluation of this end point: The secondary end points 1) and 2) will be evaluated during the interim analysis for the primary outcome and after completeion of all the scans , provided the interim analysis supports it. The side effects will be documented during the MRI scan visit and regularly reviewed by a local data monitoring commitee. | — |
Countries
United Kingdom
Outcome results
None listed