| CTRI Number |
CTRI/2021/07/035214 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational single arm cohort study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound based Navigation in brain tumor surgery |
|
Scientific Title of Study
|
The Clinical Value of Ultrasound based Navigation update in cranial resection procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aliasgar Moiyadi |
| Designation |
Professor, Surgical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Dr E Borges road,
Homi Bhabha Block,
12th floor, Room No 1229
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
amoiyadi@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aliasgar Moiyadi |
| Designation |
Professor, Surgical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Dr E Borges road,
Homi Bhabha Block,
12th floor, Room No 1229
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
amoiyadi@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aliasgar Moiyadi |
| Designation |
Professor, Surgical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Dr E Borges road,
Homi Bhabha Block,
12th floor, Room No 1229
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
amoiyadi@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Brainlab AG |
| Address |
Dr. Susanne Hager, MHBA/ Dimitrios Sapnaras, MBA
Brainlab AG, Olof-Palme-Strabe 9, 81829 Munich, Germany |
| Type of Sponsor |
Other [Medical equipment manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aliasgar Moiyadi |
Tata Memorial Hospital |
Dr E Borges Road,
Homi Bhabha Block,
Ground floor, OPD 057,
Parel
Mumbai
MAHARASHTRA |
02224177000
aliasgar.moiyadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Intra axial supratentorial brain tumors planned to undergo tumor resection surgery
|
|
| ExclusionCriteria |
| Details |
< 18 years of age, all other tumor lesions not described in the inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine brain shift compensation by assessing the navigation accuracy after dura opening before and after utilizing the Navigation Update feature of Brainlab’s Ultrasound Navigation software. |
intraoperative only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Extent of resection |
24hrs post surgery |
| Factors influencing the accuracy benefit |
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgical removal is often the main treatment for tumors. In order to completely remove the entire tumor, it is vital to ensure visualization into the brain to review the borders of the tumor and to not harm healthy tissue. Neuronavigation is a well-accepted method to view inside the brain during surgery. This works like a GPS system providing the neurosurgeon with intraoperative guidance based on preoperatively acquired MRI which are registered to the patient’s anatomy. However, accuracy is affected due to brain shift or the movement of the brain after opening the dura or resection of the tumor. Intraoperative ultrasound navigation can be used to compensate for brain shift by providing updated real-time accurate information of the surgical field. the real-time ultrasound is fused with the MRI to update its accuracy. This project is intended to quantify the hypothesized improvement in navigation accuracy using Brainlab’sUltrasound Navigation software and determine if using a navigation update feature can compensate for brainshift and therefore improve navigation accuracy and hence, positively influence extent of resection. |