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Sonography-guided Resection of Brain Mass Lesions (SOMALI)

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ClinicalTrials.gov Identifier: NCT05484245
Recruitment Status : Recruiting
First Posted : August 2, 2022
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Alexander Dmitriev, Sklifosovsky Institute of Emergency Care

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tumor, Brain Arteriovenous Malformations Cavernoma Intracerebral Hematoma Device: Sonography Not Applicable

Detailed Description:

Intraoperative sonography is usially used in neurooncology to detect brain tumors and exclude their remnants. A few studies describe it's usage while removing hematomas or vascular malformations. Ultrasound is the only method allowing to observe brain tissue in real time. It is chip and doesn't violate surgical workflow. Main disadvantages of sonography are lengthy learning curve and poorer image quality compared to magnetic resonance imaging. Novel acoustic coupling fluid, contrast-enhanced ultrasound and elastography expanded it's effectiveness. Meanwhile problems of locating of isoechogenic lesions with poor margins and elimination of artefacts are steel actual.

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.

A surgeon will intraoperatively locate mass lesion and assess extent of it's resection with sonography. Ultrasound scanning will be performed through the same surgical approach or at a distance through enlarged craniotomy, periodically or permanently. To facilitate approach to subcortical and deep small mass lesions ultrasound-guided needle or ultrasound wire-guided port will be used.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery
Ultrasound-guided resection of brain tumors, vascular malformations and hematomas
Device: Sonography
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography




Primary Outcome Measures :
  1. Ultrasound features of various brain mass lesions in Mair scale (in grades) [ Time Frame: Intraoperatively ]
    Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging


Secondary Outcome Measures :
  1. Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents) [ Time Frame: Intraoperatively ]
    Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100

  2. Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents) [ Time Frame: Within 48 hours after surgery ]
    Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100

  3. Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [ Time Frame: Within 48 hours after surgery ]
    Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100

  4. Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [ Time Frame: Within 48 hours after surgery ]
    Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100

  5. Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [ Time Frame: Within 48 hours after surgery ]
    Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100

  6. Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [ Time Frame: Within 48 hours after surgery ]
    Accuracy = (true detection of residual mass lesion + true absence of residual mass lesion) / (true detection of residual mass lesion + true absence of residual mass lesion + false detection of residual mass lesion + inability to detect residual mass lesion) x 100

  7. Duration of mass lesion removal (in minutes) [ Time Frame: Intraoperatively ]
    How long did in take to remove mass lesion from starting of it's dissection till final evacuation

  8. Extent of resection (in percents) [ Time Frame: Within 48 hours after surgery ]
    Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

  9. Differentiation between artefacts and residual lesion (Yes or No) [ Time Frame: Intraoperatively ]
    Possibility of ultrasound differentiation between artefacts and residual lesion

  10. Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes) [ Time Frame: Intraoperatively ]
    Only for subcortical or deep-seated mass lesions. How long did in take to reach margin of mass lesion after dural incision using ultrasound-guided needle or ultrasound wire-guided port

  11. Karnofsky performance status (in percents) [ Time Frame: Within 10 days after surgery ]
    Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all intracranial tumors
  • cavernomas
  • arteriovenous malformations
  • spontaneous (non-traumatic) intracerebral hemorrhages
  • traumatic intracerebral hemorrhages
  • supratentorial localization
  • newly diagnosed
  • age 18-100 years
  • stable hemodynamics

Exclusion Criteria:

  • rapid cerebral dislocation
  • previously performed brain radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05484245


Contacts
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Contact: Alexander Dmitriev, MD +7 (916) 423-54-08 dmitriev@neurosklif.ru

Locations
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Russian Federation
Sklifosovsky Institute of Emergency Care Recruiting
Moscow, Russian Federation, 129090
Contact: Alexander Dmitriev, MD    +7 (916) 423-54-08      
Sponsors and Collaborators
Sklifosovsky Institute of Emergency Care
Investigators
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Principal Investigator: Alexander Dmitriev, MD Sklifosovsky Institute of Emergency Care
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Responsible Party: Alexander Dmitriev, Principal Investigator, Sklifosovsky Institute of Emergency Care
ClinicalTrials.gov Identifier: NCT05484245    
Other Study ID Numbers: 9g
First Posted: August 2, 2022    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Dmitriev, Sklifosovsky Institute of Emergency Care:
intraoperative sonography
intraoperative ultrasound
brain tumor
cavernoma
arteriovenous malformation
intracerebral hematoma
Additional relevant MeSH terms:
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Brain Neoplasms
Hemangioma, Cavernous
Cerebral Hemorrhage
Arteriovenous Malformations
Congenital Abnormalities
Hematoma
Hemorrhage
Pathologic Processes
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders