Patients With Resectable Brain Tumors
Conditions
Keywords
Malignant gliomas, Sono RCT
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).
Interventions
DEVICESonowand
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
PROCEDURENavigation
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.
Sponsors
Tata Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients where Gross total resection (GTR) achieved | Post operative within 72 hrs. | Measure: Volumetric MRI - residual tumor (in cc) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of US | Post operative within 72 hrours | Measure: Sensitivity, Specificity, PPV, NPV |
Other
| Measure | Time frame | Description |
|---|---|---|
| Further resection prompted | Intraoperative | Whether use of the SonoWand prompted a further resection after the surgeon thought it was complete (Unanticipated residue) |
| Survival | 3 years | overall and Progression-free |
Countries
India
Outcome results
None listed