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NCT Number: NCT02150564

3D Ultra Sound for Resection of Brain Tumors

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).

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Key information

Conditions

Patients With Resectable Brain Tumors Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Centre for Treatment Research and Education in Cancer

Mumbai, Maharashtra, 410210, India

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Sonowand

Device

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

Navigation

Procedure

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.

Primary outcomes

  1. Percentage of patients where Gross total resection (GTR) achieved

    Time frame: Post operative within 72 hrs.

    Measure: Volumetric MRI - residual tumor (in cc)

Secondary outcomes

  1. Accuracy of US

    Time frame: Post operative within 72 hrours

    Measure: Sensitivity, Specificity, PPV, NPV

Other outcomes

  1. Further resection prompted

    Time frame: Intraoperative

    Whether use of the SonoWand prompted a further resection after the surgeon thought it was complete (Unanticipated residue)

  2. Survival

    Time frame: 3 years

    overall and Progression-free

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

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

Acronym: SonoRCT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 30, 2014
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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