Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-02 @ 11:24 AM
Study NCT ID:
NCT05046067
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2021-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). This makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. A 3D model may help surgeons better predict where the location of the tumor(s) will be during surgery.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.
SECONDARY OBJECTIVES:
I. Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.
II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.
OUTLINE:
Patients undergo 4 CT scans during standard of care surgery.
I. To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.
SECONDARY OBJECTIVES:
I. Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.
II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.
OUTLINE:
Patients undergo 4 CT scans during standard of care surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: