3D Ultra Sound for Resection of Brain Tumors

Not Applicable

Completed

• Conditions: Patients With Resectable Brain Tumors
• Interventions: Procedure: Navigation; Device: Sonowand

• Registration Number: NCT02150564
• Lead Sponsor: Tata Memorial Hospital

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).

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-17
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-30
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation only group	Navigation	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.
SonoRCT Test group	Sonowand	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients where Gross total resection (GTR) achieved	Post operative within 72 hrs.	Measure: Volumetric MRI - residual tumor (in cc)

Secondary Outcome Measures

Name	Time	Method
Accuracy of US	Post operative within 72 hrours	Measure: Sensitivity, Specificity, PPV, NPV

Trial Locations

Locations (1)

Advanced Centre for Treatment Research and Education in Cancer; 🇮🇳 Mumbai, Maharashtra, India