Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor MedDRA version: 15.1 Level: LLT Classification code 10053764 Term: Brain tumor operation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: SonoVue®
Product Name: SonoVue®
Product Code: SonoVue®
Pharmaceutical Form: Powder and solvent for suspension for injection
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of intraoperative, 3D reconstructed and contrast enhanced, transdural ultrasound with the preoperative 3D- MRi as Gold Standard. Comparison of intraoperative, 3D reconstructed and contrast enhanced ultrasound after tumor resection to verify the extent of resection as well as accuracy of navigation with the early post operative3D- MRi as Gold Standard ;Secondary Objective: 1) Can the use of SonoVue® improve imaging in 3D ultrasound of brain tumors? Are there differences in the quality of imaging in pre- and postoperative ultrasound? 2) Could the 3D reconstructed and contrast enhanced ultrasound figure the intraoperative brainshift correlate to anatomical structures? 3) How does the 3D reconstructed and contrast enhanced ultrasound with SonoVuo® figures the tumor in different tumor entities? ;Primary end point(s): Comparison of intraoperative, 3D reconstructed and contrast enhanced, transdural ultrasound in brain tumor operation to verify the accuracy in resection control as well as precision of navigation with the pre and postoperative 3D- MRi as Gold Standard;Timepoint(s) of evaluation of this end point: During operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Can the administration of SonoVue® improve the imaging of brain tumors? Are there pre- and postoperative differences in the expected improve of the imaging quality. (2) Can the SonoVue® contrast-enhanced ultrasound image the intraoperative brainshift in the area of the tumor in contrast to adjacent tissue and vessels? (3) How does the outcome of the SonoVue® contrast-enhanced ultrasound differ in dependance to the tumor entity? ;Timepoint(s) of evaluation of this end point: During operation | — |
Countries
Germany
Contacts
Public ContactDr. Dirk Lindner
University of Leipzig Neurochirurgie
Outcome results
None listed