3D Ultra Sound for Resection of Brain Tumors (Sono RCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02150564|
Recruitment Status : Unknown
Verified October 2016 by Dr Aliasgar V Moiyadi, Tata Memorial Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2014
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Patients With Resectable Brain Tumors||Device: Sonowand Procedure: Navigation||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||March 2017|
Navigation only group
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.
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.
Experimental: SonoRCT Test group
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.
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
- Percentage of patients where Gross total resection (GTR) achieved [ Time Frame: Post operative within 72 hrs. ]Measure: Volumetric MRI - residual tumor (in cc)
- Accuracy of US [ Time Frame: Post operative within 72 hrours ]Measure: Sensitivity, Specificity, PPV, NPV
- Further resection prompted [ Time Frame: Intraoperative ]
- Whether use of Sonowand prompted a further resection after the surgeon thought it was complete (unanticipated residue) [ Time Frame: Intra operative ]
- Survival (overall and progression-free) [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150564
|Contact: Dr Aliasgar V Moiyadi, M Ch Neurosurgery||022-27405076 ext firstname.lastname@example.org|
|Advanced Centre for Treatment Research and Education in Cancer||Recruiting|
|Mumbai, Maharashtra, India, 410210|
|Contact: Aliasgar V Moiyadi, M Ch (Neurosurgery) 91-22-27405076 ext 5076 email@example.com|
|Principal Investigator: Aliasgar V Moiyadi, M Ch, DNB (Neurosurgery)|
|Principal Investigator:||Aliasgar V Moiyadi, M Ch Neurosurgery||Prof and Neurosurgeon|