Brain-Shift Monitoring Using 3D Scanning

NCT05018338 | Terminated FDA Device

• 1 other identifier: 0100
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniotomy for Epilepsy and Malignant Tumor Removal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brain-shift measurement accuracy

  Throughout the surgical procedure

Other Outcomes (1)

• Operation of the 3D scanner

  Throughout the surgical procedure

Study Arms (1)

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

Interventions

Brain shift monitoring DEVICE

For use to monitor brain shift during craniotomy

Also known as: 3D brain scanning

The study cohort

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Scanners Inc.: lead

Study Sites (1)

St. David's Medical Center

Austin, Texas, 78758, United States

Location

Related Publications (7)

• Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).

  BACKGROUND

• 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.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 16289612 BACKGROUND

• 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.

  PMID: 17046629 BACKGROUND

• 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.

  PMID: 26590631 BACKGROUND

• 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.

  PMID: 26883549 BACKGROUND

Study Officials

• Aaron Bernstein, PhD

  Advanced Scanners Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: February 28, 2020
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)