Patients With Resectable Brain TumorsSonoRCTNCT02150564
3D Ultra Sound for Resection of Brain Tumors
A study testing Sonowand and Navigation in people with Patients With Resectable Brain Tumors, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Resectable Brain Tumors
- What is being tested?
- Sonowand and Navigation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2014to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unfit for GA
- Unwilling for the study
- Unresectable lesion
Trial locations and contacts
1 site in 1 country.
India1 site
Advanced Centre for Treatment Research and Education in Cancer
Mumbai, Maharashtra, 410210
About this study
Official title: Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
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).
Read the detailed description
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).
- Conditions
- Patients With Resectable Brain Tumors
- Being tested
- Sonowand, Navigation
- Keywords
- Malignant gliomas, Sono RCT
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
NavigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sonowand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients where Gross total resection (GTR) achieved
Measure: Volumetric MRI - residual tumor (in cc)
Measured: Post operative within 72 hrs.
Secondary outcomes (1)
Accuracy of US
Measure: Sensitivity, Specificity, PPV, NPV
Measured: Post operative within 72 hrours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMar 2014
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Resectable Brain TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Aliasgar V Moiyadi, Tata Memorial Hospital
- Investigators
- Aliasgar V Moiyadi, Neurosurgery, Principal investigator, Prof and Neurosurgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150564
- Sponsor's protocol ID
- TMC-ACTREC 101
- Acronym
- SonoRCT
- Status last verified
- May 2022
- First submitted
- 17 May 2014
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02150564
- Acronym / sponsor ID
- SonoRCT / TMC-ACTREC 101
- Conditions
- Patients With Resectable Brain Tumors
- Keywords
- Malignant gliomas, Sono RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Mar 2014
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation only group | Other | Procedure: NavigationSonowand 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. |
| SonoRCT Test group | Experimental | Device: SonowandSurgery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unfit for GA
- Unwilling for the study
- Unresectable lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonowandInitially 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 | Device | SonoRCT Test group |
| NavigationRoutine 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. | Procedure or surgery | Navigation only group |
Primary outcome
Percentage of patients where Gross total resection (GTR) achieved
Time frame: Post operative within 72 hrs.
Measure: Volumetric MRI - residual tumor (in cc)
1 secondary outcome
Accuracy of US
Time frame: Post operative within 72 hrours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliasgar V Moiyadi, Neurosurgery principal investigator
Prof and Neurosurgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonowand and Navigation in people with Patients With Resectable Brain Tumors, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients where Gross total resection (GTR) achieved (time frame: Post operative within 72 hrs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.