3D Ultra Sound for Resection of Brain Tumors (SonoRCT)

Tata Memorial Hospital

Status: Completed

Conditions: Patients With Resectable Brain Tumors

Treatments: Device: Sonowand; Procedure: Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02150564

TMC-ACTREC 101

Details and patient eligibility

About

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).

Full 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).

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Navigation only group

Other group

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.

Treatment:

Procedure: Navigation

SonoRCT Test group

Experimental group

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.

Treatment:

Device: Sonowand