Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients With Resectable Brain Tumors
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Percentage of patients where Gross total resection (GTR) achieved
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
Dr Aliasgar V Moiyadi
Prof and Neurosurgeon
Tata Memorial Hospital
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
Outcomes
Primary Outcomes
Percentage of patients where Gross total resection (GTR) achieved
Time Frame: Post operative within 72 hrs.
Measure: Volumetric MRI - residual tumor (in cc)
Secondary Outcomes
- Accuracy of US(Post operative within 72 hrours)