Brain-Shift Monitoring Using 3D Scanning
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Brain shift monitoring
For use to monitor brain shift during craniotomy
Other Names:
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Outcome Measures
Primary Outcome Measures
- Brain-shift measurement [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.
Secondary Outcome Measures
- Brain-shift measurement accuracy [Throughout the surgical procedure]
Measurement of brain-shift in human subjects' brains with sub-mm accuracy using our scanning technology
Other Outcome Measures
- Operation of the 3D scanner [Throughout the surgical procedure]
Successful operation of the scanner providing periodic feedback to the surgeon
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female ≥ 6 years of age at Visit 1.
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Clinically planned for craniotomy, including for malignant tumors, whether awake or under general anesthesia.
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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.
Exclusion Criteria:
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Language problems that would prevent from properly understanding instructions.
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Requirement of an interpreter.
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Patients who are excluded from consideration for the clinical operation are therefore excluded from the research study.
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Special populations: pregnant women, prisoners.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. David's Medical Center | Austin | Texas | United States | 78758 |
Sponsors and Collaborators
- Advanced Scanners Inc.
Investigators
- Study Director: Aaron Bernstein, PhD, Advanced Scanners Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- Arlt F, Chalopin C, Müns 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.
- Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).
- Hameeteman 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.
- Kovacs L, Zimmermann A, Brockmann G, Gühring 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. Epub 2006 Mar 9.
- 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. Epub 2005 Nov 9.
- 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).
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