3D Printing for Pre-Surgical Planning

NCT05144620 | Completed

• 1 other identifier: 21-3135.cc
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an inherently intuitive manner that cannot be achieved with conventional methods of imaging review that use screen based 2D and volume rendered representations. The investigators are developing a novel technique to create 3D models derived directly from extremely high-resolution medical images that are superior in spatial and contrast resolution to current 3D modelling methods. This produces patient specific models that contain previously unachievable special fidelity and soft tissue differentiation. Investigators hypothesize that the preoperative use of these new diagnostic quality models will reduce surgical time and improve post-surgical outcomes in the near future. This prospective project will optimize the quality of these 3D models to create highly useful pre-surgical models. Investigators will target those subspecialist areas of the multidisciplinary surgical and imaging team where it is believed these models will have the most impact. The proposed prospective study has two major goals: 1) Investigate the use of uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with identical spatial/contrast resolution to the acquired datasets in the target areas of congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare the accuracy of this innovative method for 3D printing to radiological images and pathological data when available.

Conditions

Surgical Patients

Outcome Measures

Primary Outcomes (1)

• Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time

  Focus on using pre-operative imaging for producing 3D models for 3 specific presurgical evaluations 1) Adult Clear Cell Renal Mass with a focus on partial nephrectomies. 2) Pediatric Cardiothoracic Surgery 3) Pediatric Neurosurgical primary brain tumor resection involving eloquent areas of the brain (eg speech center, auditory center, visual center, motor cortex, and sensory cortex). 4) Plastic Surgery and Craniomaxillofacial disciplines with a focus on DIEP Flap reconstructions and Alveolar Bone Graft procedures. Change in surgical time based on using a 3D model per-operatively

  3 years

Study Arms (1)

Preoperative Imaging

EXPERIMENTAL

Diagnostic Test: 3D Mapping

Interventions

3D Mapping DIAGNOSTIC_TEST

3D model will be made from diagnostic imaging for pre-surgical planning

Preoperative Imaging

Eligibility Criteria

• Age: 1 Month - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients seen at UCHealth/CHCO and NOC sites between 6/1/2021 - 6/1/2026
• Pregnant women and their fetuses

You may not qualify if:

• \- Patients 65 and older

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80217-3364, United States

Location

Related Publications (1)

• Jacobson NM, Carerra E, Treat A, McDonnell M, Mathes D, Kaoutzanis C. Hybrid modeling techniques for 3D printed deep inferior epigastric perforator flap models. 3D Print Med. 2023 Sep 12;9(1):26. doi: 10.1186/s41205-023-00181-z.

  PMID: 37700101 DERIVED

Study Officials

• Nicholas Jacobson

  Colorado Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 3, 2021
• Study Start: December 30, 2021
• Primary Completion: December 7, 2022
• Study Completion: June 19, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)