Brain-Shift Monitoring Using 3D Scanning
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Aaron Bernstein, PhD
- 电话号码：(505) 550-1846
- 邮箱：aaronb@advancedscanners.com
研究联系人备份
- 姓名：Anant I Patel, MD
- 电话号码：(512) 837-7999
- 邮箱：anant.md@gmail.com
学习地点
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Texas
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Austin、Texas、美国、78758
- 招聘中
- St. David's Medical Center
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接触：
- Anant I Patel, MD
- 电话号码：(512) 837-7999
- 邮箱：anant.md@gmail.com
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接触：
- Anant I Patel, MD
- 电话号码：512-837-7999
- 邮箱：anant.md@gmail.com
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首席研究员：
- Anant I Patel, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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For use to monitor brain shift during craniotomy
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Brain-shift measurement
大体时间：Throughout the surgical procedure
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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.
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Throughout the surgical procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Brain-shift measurement accuracy
大体时间：Throughout the surgical procedure
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Measurement of brain-shift in human subjects' brains with sub-mm accuracy using our scanning technology
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Throughout the surgical procedure
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Operation of the 3D scanner
大体时间：Throughout the surgical procedure
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Successful operation of the scanner providing periodic feedback to the surgeon
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Throughout the surgical procedure
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合作者和调查者
调查人员
- 研究主任：Aaron Bernstein, PhD、Advanced Scanners Inc.
出版物和有用的链接
一般刊物
- Arlt 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.
- 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, 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.
- 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.
- 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).
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Brain shift monitoring的临床试验
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Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United Kingdom完全的
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Mayo ClinicNational Institute on Aging (NIA); University of Minnesota; Georgia Institute of Technology完全的
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Indiana University完全的