Sonography-guided Resection of Brain Mass Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSklifosovsky Institute of Emergency Care
About this trial
Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all intracranial tumors
cavernomas
arteriovenous malformations
spontaneous (non-traumatic) intracerebral hemorrhages
Disqualifiers
rapid cerebral dislocation
previously performed brain radiotherapy
Trial design
Design model
Single group
Treatments tested in this trial
Sonography
DeviceSurgeon detects brain mass lesion and assesses extent of it's resection with sonography
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ultrasound features of various brain mass lesions in Mair scale (in grades)
Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging
Time frame
IntraoperativelySecondary outcomes
1
Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)
Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100
Time frame
Intraoperatively2
Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100
Time frame
Within 48 hours after surgery3
Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100
Time frame
Within 48 hours after surgery4
Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100
Time frame
Within 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov