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Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

Primary Purpose

Lung Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Therapeutic Conventional Surgery
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive)
  • Patient is scheduled for surgical resection in a room equipped with intraoperative CT
  • Patient must sign informed consent, with risks and benefits of CT imaging explained
  • Patients with lung tumors >= 1cm to =< 3 cm based on preoperative CT scan. (Patients with lung tumors from < 1 cm or > 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators)

Exclusion Criteria:

  • Pediatric patients less than 18 years of age
  • Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively
  • Patients who received neoadjuvant immunotherapy
  • Women who are pregnant or nursing

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CT)

Arm Description

Patients undergo 4 CT scans during standard of care surgery.

Outcomes

Primary Outcome Measures

Feasibility of anatomical modeling for image guided thoracic surgery
The geometrical accuracy of the models for localizing the tumor will be quantified. The study is feasible if tumors for all 10 patients can be located with accuracy of within 1 cm or less. Anatomical modeling for image guided thoracic surgery will be considered feasible if researchers are able to determine the location of the tumor in a deflated lung to within the accuracy required by the surgeon for clinical use.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2021
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05046067
Brief Title
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Official Title
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CT)
Arm Type
Experimental
Arm Description
Patients undergo 4 CT scans during standard of care surgery.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo surgery per standard of care
Primary Outcome Measure Information:
Title
Feasibility of anatomical modeling for image guided thoracic surgery
Description
The geometrical accuracy of the models for localizing the tumor will be quantified. The study is feasible if tumors for all 10 patients can be located with accuracy of within 1 cm or less. Anatomical modeling for image guided thoracic surgery will be considered feasible if researchers are able to determine the location of the tumor in a deflated lung to within the accuracy required by the surgeon for clinical use.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive) Patient is scheduled for surgical resection in a room equipped with intraoperative CT Patient must sign informed consent, with risks and benefits of CT imaging explained Patients with lung tumors >= 1cm to =< 3 cm based on preoperative CT scan. (Patients with lung tumors from < 1 cm or > 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators) Exclusion Criteria: Pediatric patients less than 18 years of age Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively Patients who received neoadjuvant immunotherapy Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Rajaram
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Rajaram
Phone
713-563-4530
Email
rrajaram@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ravi Rajaram

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

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