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Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05046067
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
15.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Procedure: Therapeutic Conventional Surgery
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Actual Study Start Date :
Sep 16, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (CT)

Patients undergo 4 CT scans during standard of care surgery.

Procedure: Computed Tomography
Undergo CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

    • Procedure: Therapeutic Conventional Surgery
    Undergo surgery per standard of care

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of anatomical modeling for image guided thoracic surgery [Up to 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Ravi Rajaram, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05046067
    Other Study ID Numbers:
    • 2019-1189
    • NCI-2021-06616
    • 2019-1189
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2022