3D Ultra Sound for Resection of Brain Tumors

Tata Memorial Hospital72 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Patients With Resectable Brain Tumors

Interventions

SonowandDEVICE

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

NavigationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Advanced Centre for Treatment Research and Education in Cancer

Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Percentage of patients where Gross total resection (GTR) achieved

Measure: Volumetric MRI - residual tumor (in cc)

Time frame: Post operative within 72 hrs.

Secondary Outcomes

Accuracy of US

Measure: Sensitivity, Specificity, PPV, NPV

Time frame: Post operative within 72 hrours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.