Craniotomy for Epilepsy and Malignant Tumor RemovalNCT05018338
Brain-Shift Monitoring Using 3D Scanning
An observational study of Craniotomy for Epilepsy and Malignant Tumor Removal, run by Advanced Scanners Inc. at 1 site in United States.
Trial summary
A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery. The primary objective is to evaluate the performance of the scanner in determining the brain surface shape over multiple time points during craniotomies (surgical opening into… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Craniotomy for Epilepsy and Malignant Tumor Removal
- What is being tested?
- Brain shift monitoring
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 28 Feb 2020
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects seen by Dr. Anat I. Patel (neurosurgeon) and scheduled for craniotomy at St. David's North Austin Medical Center are the potential population for this study.
Who may be able to join
- Male or female ≥ 6 years of age at Visit 1.
- Clinically planned for craniotomy, including for malignant tumors, whether awake or under general anesthesia.
- Able to provide written informed consent (and assent when applicable) - by subject or subject's legal representative - and agrees to comply with the requirements of the study.
Who cannot join
- Language problems that would prevent from properly understanding instructions.
- Requirement of an interpreter.
- Patients who are excluded from consideration for the clinical operation are therefore excluded from the research study.
- Special populations: pregnant women, prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-pilot Study of Brain-Shift Monitoring Using 3D Scanning
A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery.
The primary objective is to evaluate the performance of the scanner in determining the brain surface shape over multiple time points during craniotomies (surgical opening into the skull), and present those shapes in full color, with high resolution in all three coordinates of 3D space. A secondary objective is to use the measurements to determine brain shift as a function of time.
Read the detailed description
The scanner sterilization will largely follow procedures used currently for cameras and microscopes: the scanner will be draped in a disposable drape custom manufactured for the device by a leading instrument drape manufacturer (Medline). The drape will be windowed with a sterilized shatterproof plastic optical window. Standard hospital procedures will be followed for the disposal of instrument drapes. The drape will be sterile and wrapped in the conventional manner, and the drape itself will be disposable. Prior to surgery, the drape, window and frame will undergo the same sterilization procedure as other equipment. If window transparency is compromised during surgery, it can be cleaned with a cleaning agent.
The scanner will illuminate the craniotomy region with light for the duration of its use, which may be for the duration of the surgery. The scanner will be anywhere from 8 to 12 inches away from the patient, illuminating the subject's brain by the scanner light for 2 minutes at a time, or continuously, either with or without maximum overhead lighting.
For each patient, the duration of obtaining data will last for the duration of the clinical operation procedure. The 3D Scanner on and off time would add less than 5 minutes to the procedure, not including measurement time.
- Being tested
- Brain shift monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain shift monitoringDevice
Also called 3D brain scanning
For use to monitor brain shift during craniotomy
| Study group | Role | What they receive |
|---|---|---|
| The study cohort | The study will enroll 10 subjects meeting the eligibility criteria, with the expectation to obtain complete data from at least 6 subjects. Receives: Device: Brain shift monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain-shift measurement
Measure brain-shift in human subjects' brains with our scanning technology, and compare with preoperative MRI or CT, and, optionally, with inter-operative or postoperative MRI or CT scans. Measurements will include changes, measured in millimeters, of the surface anatomic features of the brain from the optical scans. Overall topological changes will also be measured between pre- and post-operative CT/MRI imaging of the patient with the optical scans. All these measurements will be performed using co-registered surfaces, reporting specifically computer-determined measurement of distances between those surfaces.
Measured: Throughout the surgical procedure
Secondary outcomes (1)
Brain-shift measurement accuracy
Measurement of brain-shift in human subjects' brains with sub-mm accuracy using our scanning technology
Measured: Throughout the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start28 Feb 2020
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: Low enrollment of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Craniotomy for Epilepsy and Malignant Tumor RemovalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Scanners Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Bernstein, PhD, Study director, Advanced Scanners Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018338
- Sponsor's protocol ID
- 0100
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: If data is shared, it will be anonymized.
Publications
Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).
Yang, J. C. et al., Journal of Clinical Neuroscience 21, p. 1230 (2014) and Mert, A. et al, Operative Neurosurgery 71, p. 286 (2012), respectively.
Zhang, D., Lu, G., Li, W., Zhang, L. & Luo, N. Palmprint Recognition Using 3-D Information. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 39, 505-519 (2009).
Park HK, Chung JW, Kho HS. Use of hand-held laser scanning in the assessment of craniometry. Forensic Sci Int. 2006 Jul 13;160(2-3):200-6. doi: 10.1016/j.forsciint.2005.10.007. Epub 2005 Nov 9.
PubMed 16289612Kovacs L, Zimmermann A, Brockmann G, Guhring M, Baurecht H, Papadopulos NA, Schwenzer-Zimmerer K, Sader R, Biemer E, Zeilhofer HF. Three-dimensional recording of the human face with a 3D laser scanner. J Plast Reconstr Aesthet Surg. 2006;59(11):1193-202. doi: 10.1016/j.bjps.2005.10.025. Epub 2006 Mar 9.
PubMed 17046629Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016/j.bjps.2015.10.011. Epub 2015 Oct 22.
PubMed 26590631Arlt F, Chalopin C, Muns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007/s00701-016-2738-z. Epub 2016 Feb 16.
PubMed 26883549
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-pilot Study of Brain-Shift Monitoring Using 3D Scanning
- ClinicalTrials.gov ID
- NCT05018338
- Acronym / sponsor ID
- 0100
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment of subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Advanced Scanners Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 24 Aug 2021 (actual)
- 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.
A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery.
The primary objective is to evaluate the performance of the scanner in determining the brain surface shape over multiple time points during craniotomies (surgical opening into the skull), and present those shapes in full color, with high resolution in all three coordinates of 3D space. A secondary objective is to use the measurements to determine brain shift as a function of time.
Detailed description
The scanner sterilization will largely follow procedures used currently for cameras and microscopes: the scanner will be draped in a disposable drape custom manufactured for the device by a leading instrument drape manufacturer (Medline). The drape will be windowed with a sterilized shatterproof plastic optical window. Standard hospital procedures will be followed for the disposal of instrument drapes. The drape will be sterile and wrapped in the conventional manner, and the drape itself will be disposable. Prior to surgery, the drape, window and frame will undergo the same sterilization procedure as other equipment. If window transparency is compromised during surgery, it can be cleaned with a cleaning agent.
The scanner will illuminate the craniotomy region with light for the duration of its use, which may be for the duration of the surgery. The scanner will be anywhere from 8 to 12 inches away from the patient, illuminating the subject's brain by the scanner light for 2 minutes at a time, or continuously, either with or without maximum overhead lighting.
For each patient, the duration of obtaining data will last for the duration of the clinical operation procedure. The 3D Scanner on and off time would add less than 5 minutes to the procedure, not including measurement time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study cohort | – | Device: Brain shift monitoringThe study will enroll 10 subjects meeting the eligibility criteria, with the expectation to obtain complete data from at least 6 subjects. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects seen by Dr. Anat I. Patel (neurosurgeon) and scheduled for craniotomy at St. David's North Austin Medical Center are the potential population for this study.
Key inclusion criteria (3 listed)
- Male or female ≥ 6 years of age at Visit 1.
- Clinically planned for craniotomy, including for malignant tumors, whether awake or under general anesthesia.
- Able to provide written informed consent (and assent when applicable) - by subject or subject's legal representative - and agrees to comply with the requirements of the study.
Key exclusion criteria (4 listed)
- Language problems that would prevent from properly understanding instructions.
- Requirement of an interpreter.
- Patients who are excluded from consideration for the clinical operation are therefore excluded from the research study.
- Special populations: pregnant women, prisoners.
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 |
|---|---|---|
| Brain shift monitoringAlso: 3D brain scanningFor use to monitor brain shift during craniotomy | Device | The study cohort |
Primary outcome
Brain-shift measurement
Time frame: Throughout the surgical procedure
Measure brain-shift in human subjects' brains with our scanning technology, and compare with preoperative MRI or CT, and, optionally, with inter-operative or postoperative MRI or CT scans. Measurements will include changes, measured in millimeters, of the surface anatomic features of the brain from the optical scans. Overall topological changes will also be measured between pre- and post-operative CT/MRI imaging of the patient with the optical scans. All these measurements will be performed using co-registered surfaces, reporting specifically computer-determined measurement of distances between those surfaces.
1 secondary outcome
Brain-shift measurement accuracy
Time frame: Throughout the surgical procedure
Results and safety
The study was stopped early (reason given: Low enrollment of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- BackgroundDaanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).
- BackgroundYang, J. C. et al., Journal of Clinical Neuroscience 21, p. 1230 (2014) and Mert, A. et al, Operative Neurosurgery 71, p. 286 (2012), respectively.
- BackgroundZhang, D., Lu, G., Li, W., Zhang, L. & Luo, N. Palmprint Recognition Using 3-D Information. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 39, 505-519 (2009).
- Background: PubMed 16289612Park HK, Chung JW, Kho HS. Use of hand-held laser scanning in the assessment of craniometry. Forensic Sci Int. 2006 Jul 13;160(2-3):200-6. doi: 10.1016/j.forsciint.2005.10.007. Epub 2005 Nov 9.
- Background: PubMed 17046629Kovacs L, Zimmermann A, Brockmann G, Guhring M, Baurecht H, Papadopulos NA, Schwenzer-Zimmerer K, Sader R, Biemer E, Zeilhofer HF. Three-dimensional recording of the human face with a 3D laser scanner. J Plast Reconstr Aesthet Surg. 2006;59(11):1193-202. doi: 10.1016/j.bjps.2005.10.025. Epub 2006 Mar 9.
- Background: PubMed 26590631Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016/j.bjps.2015.10.011. Epub 2015 Oct 22.
- Background: PubMed 26883549Arlt F, Chalopin C, Muns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007/s00701-016-2738-z. Epub 2016 Feb 16.
- Individual participant dataSharing planned: Undecided. If data is shared, it will be anonymized.
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.
Aaron Bernstein, PhD study director
Advanced Scanners Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy for Epilepsy and Malignant Tumor Removal, run by Advanced Scanners Inc. at 1 site in United States.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Oct 2025. 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 United States. 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 was stopped early (reason given: Low enrollment of subjects). Results are not available in the source record.
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?
Brain-shift measurement (time frame: Throughout the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018338, which also lists 7 linked publications.
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 2 Oct 2025.