3D Ultra Sound for Resection of Brain Tumors

Patients With Resectable Brain Tumors Clinical Trial

— SonoRCT  

Official title:

Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150564
• Other study ID #: TMC-ACTREC 101
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2022
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Patients With Resectable Brain Tumors

Intervention

Device:
• Sonowand
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

Procedure:
• Navigation
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.

Locations

Country	Name	City	State
India	Advanced Centre for Treatment Research and Education in Cancer	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Further resection prompted	Whether use of the SonoWand prompted a further resection after the surgeon thought it was complete (Unanticipated residue)	Intraoperative
Other	Survival	overall and Progression-free	3 years
Primary	Percentage of patients where Gross total resection (GTR) achieved	Measure: Volumetric MRI - residual tumor (in cc)	Post operative within 72 hrs.
Secondary	Accuracy of US	Measure: Sensitivity, Specificity, PPV, NPV	Post operative within 72 hrours