3D Ultra Sound for Resection of Brain Tumors
Conditions
Patients With Resectable Brain Tumors
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
Malignant gliomas, Sono RCT
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Sonowand Type: Device
Name: Navigation Type: Procedure
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.

2. Adults (above 18 years)

3. Eligible for surgical therapy (craniotomy not stereotactic biopsy )

4. 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:

1. Unfit for GA

2. Unwilling for the study

3. Unresectable lesion
Location
Advanced Centre for Treatment Research and Education in Cancer
Mumbai, Maharashtra, India
Status: Recruiting
Contact: Aliasgar V Moiyadi, M Ch (Neurosurgery) - 91-22-27405076 - aliasgar.moiyadi@gmail.com
Start Date
March 2014
Completion Date
March 2017
Sponsors
Tata Memorial Hospital
Source
Tata Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page