Pilot study on use of Sulphur hexafluoride Microbubbles (SonoVue®) as a Magnetic Resonance Imaging contrast agent in the imaging of brain tumours.

• Conditions: Patients undergoing pre-operative/follow up MRI investigation for a known enhancing brain tumour; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000630-35-GB
• Lead Sponsor: Alder Hey Children's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-03
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified