Back to results3D Ultra Sound for Resection of Brain Tumors (SonoRCT)
Primary Purpose
Patients With Resectable Brain Tumors
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sonowand
Navigation
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With Resectable Brain Tumors focused on measuring Malignant gliomas, Sono RCT
Eligibility Criteria
Inclusion Criteria:
- All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.
- Adults (above 18 years)
- Eligible for surgical therapy (craniotomy not stereotactic biopsy )
- Resectability : A lesion would be considered "resectable" if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). Only deemed resectable lesions will be included
Exclusion Criteria:
- Unfit for GA
- Unwilling for the study
- Unresectable lesion
Sites / Locations
- Advanced Centre for Treatment Research and Education in Cancer
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Navigation only group
SonoRCT Test group
Arm Description
Sonowand system will be used for navigation control arm as well as sononavigation experimental arm.Navigation will be used to plan the craniotomy and throughout the procedure as desired by the operating surgeon. At no point of time however will the Ultrasound be used.
Surgery to resect the tumor with the aid of sononavigation. In addition to the navigation function, the Ultrasound will be available at all times. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue.
Outcomes
Primary Outcome Measures
Percentage of patients where Gross total resection (GTR) achieved
Measure: Volumetric MRI - residual tumor (in cc)
Secondary Outcome Measures
Accuracy of US
Measure: Sensitivity, Specificity, PPV, NPV
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02150564
Brief Title
3D Ultra Sound for Resection of Brain Tumors
Acronym
SonoRCT
Official Title
Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand) in improving the extent of resection in intra-axial brain tumors. All patients will undergo resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the standard arm, only navigation will be used. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue (histopathological correlation).
Detailed Description
Routine presurgical evaluation of all patients will be conducted. The preoperative use of steroids, antiepileptics and other medications would be as per standard procedure and would be documented. In addition detailed MRI evaluation will be performed (including contrast enhanced MRI study, diffusion MRI, perfusion MR, MR spectroscopy, dynamic-contrast-enhanced MRI for permeability studies, as well as functional MRI, and tractography if required) not more than 1 week prior to the date of surgery.
Navigation specific MR sequences would be performed in all patients (both arms).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Resectable Brain Tumors
Keywords
Malignant gliomas, Sono RCT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navigation only group
Arm Type
Other
Arm Description
Sonowand system will be used for navigation control arm as well as sononavigation experimental arm.Navigation will be used to plan the craniotomy and throughout the procedure as desired by the operating surgeon. At no point of time however will the Ultrasound be used.
Arm Title
SonoRCT Test group
Arm Type
Experimental
Arm Description
Surgery to resect the tumor with the aid of sononavigation. In addition to the navigation function, the Ultrasound will be available at all times. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue.
Intervention Type
Device
Intervention Name(s)
Sonowand
Intervention Description
Initially a 2D acquisition will be performed and ultrasound parameters adjusted to obtain the best image resolution. Then anatomical landmarks will be identified if possible and the lesioncharacterized. Once the lesion is identified a rapid 3D-US acquisition will be performed. Tumor resection will proceed guided by the 3D US images using a trackable pointer to navigate. Repeat 3D US images will be obtained as many times as required during the surgery to update the information as tumor debulking proceeds. A final US will be obtained at the end of the procedure and after dural closure
Intervention Type
Procedure
Intervention Name(s)
Navigation
Intervention Description
Routine microneurosurgical procedures would be adopted in all cases.Sonowand system will be used for navigation control arm as well as sononavigation experimental arm. Image registration (on the previously imported DICOM images) will be done on the system and after positioning, patient-toimage registration will be completed. The Registration accuracy will be documented.
Primary Outcome Measure Information:
Title
Percentage of patients where Gross total resection (GTR) achieved
Description
Measure: Volumetric MRI - residual tumor (in cc)
Time Frame
Post operative within 72 hrs.
Secondary Outcome Measure Information:
Title
Accuracy of US
Description
Measure: Sensitivity, Specificity, PPV, NPV
Time Frame
Post operative within 72 hrours
Other Pre-specified Outcome Measures:
Title
Further resection prompted
Description
Whether use of the SonoWand prompted a further resection after the surgeon thought it was complete (Unanticipated residue)
Time Frame
Intraoperative
Title
Survival
Description
overall and Progression-free
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.
Adults (above 18 years)
Eligible for surgical therapy (craniotomy not stereotactic biopsy )
Resectability : A lesion would be considered "resectable" if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). Only deemed resectable lesions will be included
Exclusion Criteria:
Unfit for GA
Unwilling for the study
Unresectable lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aliasgar V Moiyadi, Neurosurgery
Organizational Affiliation
Prof and Neurosurgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Centre for Treatment Research and Education in Cancer
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
410210
Country
India
12. IPD Sharing Statement
Learn more about this trial
3D Ultra Sound for Resection of Brain Tumors
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