Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

Not Applicable

Completed

• Conditions: Lung Neoplasm
• Interventions: Procedure: Computed Tomography; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT05046067
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-16
• Status Verified: 2024-07
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CT)	Computed Tomography	Patients undergo 4 CT scans during standard of care surgery.
Diagnostic (CT)	Therapeutic Conventional Surgery	Patients undergo 4 CT scans during standard of care surgery.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States