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3D Ultra Sound for Resection of Brain Tumors

NCT02150564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-05-09

No results posted yet for this study

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).

Conditions

  • Patients With Resectable Brain Tumors

Interventions

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.

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Aliasgar V Moiyadi, Neurosurgery · Prof and Neurosurgeon

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150564 on ClinicalTrials.gov