Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

Lung Neoplasm Clinical Trial

Official title:

Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046067
• Other study ID #: 2019-1189
• Secondary ID: NCI-2021-0661620
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year

External Links

•   MD Anderson Cancer Center Website