NCT02150564

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

5.3 years

First QC Date

May 17, 2014

Last Update Submit

May 2, 2022

Conditions

Patients With Resectable Brain Tumors

Keywords

Malignant gliomasSono RCT

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients where Gross total resection (GTR) achieved

    Measure: Volumetric MRI - residual tumor (in cc)

    Post operative within 72 hrs.

Secondary Outcomes (1)

  • Accuracy of US

    Post operative within 72 hrours

Other Outcomes (2)

  • Further resection prompted

    Intraoperative

  • Survival

    3 years

Study Arms (2)

Navigation only group

OTHER

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.

Procedure: Navigation

SonoRCT Test group

EXPERIMENTAL

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.

Device: Sonowand

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

SonoRCT Test group
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.

Navigation only group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.
  • Adults (above 18 years)
  • Eligible for surgical therapy (craniotomy not stereotactic biopsy )
  • 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

You may not qualify if:

  • Unfit for GA
  • Unwilling for the study
  • Unresectable lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Centre for Treatment Research and Education in Cancer

Mumbai, Maharashtra, 410210, India

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Aliasgar V Moiyadi, Neurosurgery

    Prof and Neurosurgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof and Neurosurgeon

Study Record Dates

First Submitted

May 17, 2014

First Posted

May 30, 2014

Study Start

March 1, 2014

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

IN(1)