Pilot study to optimise the use and to evaluate the diagnostic value of intraoperative contrast-enhanced 3D-ultrasound with SonoVue® for imaging of intracranial tumors

• Conditions: Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor; MedDRA version: 15.1Level: LLTClassification code 10053764Term: Brain tumor operationSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2010-022057-42-DE
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-25
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

– signed informed consent of the patient
– age = 18 years
– Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor.
– Ensured tumor in cranial MRi
I) Astrocytic tumors
II) Oligodendroglioma
III) Ependymoma
IV) Plexus choroidea Tumors
V) Pineal Tumors
VI) Embryonal Tumors
VII) Meningeal Tumors
VIII) Lymphoma
IX) Tumors of the Sella
X) Metsatasis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

– ASA 4 classificated patient
– Acute coronary syndrome
– Acute angina pectoris
– Disheveled Hypertension
– Acute heart failure
– NYHA III-IV
– Pulmonarey hypertension (>90 mmHg)
– Left-right reverals
– Heart intervention briefer 2 weeks
– Endocerditis
– Need of dialysis
– Hepatic insufficient
– Acute Sepsis
– ARDS (Acute Respiratory Distress Syndrom)
– Acute respiratory distress
– Allergy for SonoVue®
– Allergy for coupling agent
– Participation in other clinical trails
– Pregnant or nursing women
– No compliante patient
– Actual drug abuse
– Fertile women with no appropriate contraception or no longer than two years after the last menstruation

Study & Design

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