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.

Study Overview

• Status: Terminated
• Conditions: Craniotomy for Epilepsy and Malignant Tumor Removal
• Intervention / Treatment: Device: Brain shift monitoring

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • St. David's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Male or female ≥ 6 years of age at Visit 1.
2. Clinically planned for craniotomy, including for malignant tumors, whether awake or under general anesthesia.
3. 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:

1. Language problems that would prevent from properly understanding instructions.
2. Requirement of an interpreter.
3. Patients who are excluded from consideration for the clinical operation are therefore excluded from the research study.
4. Special populations: pregnant women, prisoners.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: 3D brain scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Throughout the surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain-shift measurement accuracy	Measurement of brain-shift in human subjects' brains with sub-mm accuracy using our scanning technology	Throughout the surgical procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation of the 3D scanner	Successful operation of the scanner providing periodic feedback to the surgeon	Throughout the surgical procedure

Collaborators and Investigators

• Sponsor: Advanced Scanners Inc.
• Investigators: Study Director: Aaron Bernstein, PhD, Advanced Scanners Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Epilepsy
• Other Study ID Numbers: 0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If data is shared, it will be anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No